Select how often (in days) to receive an alert: Senior Manager, Regulatory Affairs Date: 23 Apr 2025 Location: Uxbridge, United Kingdom, UB8 1DH Passion for Innovation. Compassion for Patients. With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones. Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada. Senior Manager, Regulatory Affairs Grade: 7 Hours: Full time, Hybrid, Head Office and Home based, with a need to travel to various locations depending on business need. Purpose: To provide regulatory guidance and support and execute regulatory activities in the UK for assigned marketed products and development projects. Accountabilities / Measures: For an assigned product portfolio, act as the regulatory liaison and contact person for the MHRA, support or lead negotiations on regulatory issues and organise meetings and teleconferences. In close collaboration with the UK, European and Global Regulatory Team develop regulatory strategies and advice, and provide clear guidance and information to internal and external stakeholders on behalf of Daiichi Sankyo. In collaboration with the European and Global Regulatory Team plan, lead and manage regulatory submissions to MHRA during product development and lifecycle management. Advise on national submission matters and any specific additional national requirements, identify deficiencies requiring resolution. Prepare gap analyses of UK documentation vs. EU and global requirements. Provide launch support and advise on supply questions of medicinal products to patients. Maintain licences of approved products, initiate and supervise implementation of changes; provide oversight and ensure regulatory compliance. Keep the European headquarters informed about the status of submissions and implementation of changes. Independently manage coordination and preparation of regulatory documents for UK submission, review regulatory and related documents for sign off prior to submission. This includes any national documents required for submission and for labelling and artwork implementation. Act as the regulatory liaison for the Daiichi Sankyo UK affiliate for a designated product range (and/or UK alliance partners). Act as the primary contact person for regulatory information and support. This includes Brand Teams, Medical, Market Access and Supply. Where required, support regulatory activities and submissions in Ireland, e.g. as absence cover. Work with the European Regulatory Team and Clinical Research Organisations to provide regulatory advice on matters related to interventional and non-interventional clinical trials in the UK if needed. Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives with particular focus on UK/MHRA national regulations. Communicate important changes and trends within Regulatory Affairs and UK affiliate business functions when relevant. Represent Regulatory Affairs and/or DS in internal and external interactions and liaise with functional groups at UK Affiliate, multidisciplinary local and multinational project and working teams, licence partners, authorities, and industry associations. Build up strong relationship with internal and external stakeholders at the UK affiliate and EU head office. Where applicable, mentor/instruct and provide guidance to internal and external reports including consultants and service providers. Plan, assign and direct work; manage competing priorities as appropriate. Lead or support projects to enhance the functionality and improve processes of the organisation and/or to adapt to a regulatory environment. Design and revise SOPs and SOIs if required. Contribute to continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP. Technical/Professional Knowledge: Degree in Pharmacy, Medicine, Life or Natural Sciences. Deep knowledge of UK/MHRA national laws, regulations, guidelines and other requirements for human medicinal product marketing authorisation and maintenance is essential. Significant level of experience (circa +5-8) years professional background in pharmaceutical industry, in Clinical Research Organisations or at a regulatory authority with +5 years proven experience in Regulatory Affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new marketing authorisations in the UK and EU. Understanding of development and life-cycle management of drugs and regulatory processes including the regulatory requirements and processes in the UK and Europe. Ability to interact and communicate effectively with regulatory authorities and external stakeholders. Working experience with MHRA. Very high ethical standards. Excellent interpersonal skills. Ability to communicate and work across functions effectively in a multinational organisation to accomplish results. Be detail-oriented, well organised and self-motivated. Proven ability to plan, coordinate and lead activities simultaneously on multiple projects. Computer proficiency (e.g. MS office, document management systems, databases), excellent written and verbal communication skills in English. PhD, post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma or Master's degree in Regulatory Affairs or other relevant specialisation. Experience in Oncology, including Project Orbis. Fluent in another European language. Why work with us? Working at Daiichi Sankyo is more than just a job - it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
Jun 04, 2025
Full time
Select how often (in days) to receive an alert: Senior Manager, Regulatory Affairs Date: 23 Apr 2025 Location: Uxbridge, United Kingdom, UB8 1DH Passion for Innovation. Compassion for Patients. With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones. Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada. Senior Manager, Regulatory Affairs Grade: 7 Hours: Full time, Hybrid, Head Office and Home based, with a need to travel to various locations depending on business need. Purpose: To provide regulatory guidance and support and execute regulatory activities in the UK for assigned marketed products and development projects. Accountabilities / Measures: For an assigned product portfolio, act as the regulatory liaison and contact person for the MHRA, support or lead negotiations on regulatory issues and organise meetings and teleconferences. In close collaboration with the UK, European and Global Regulatory Team develop regulatory strategies and advice, and provide clear guidance and information to internal and external stakeholders on behalf of Daiichi Sankyo. In collaboration with the European and Global Regulatory Team plan, lead and manage regulatory submissions to MHRA during product development and lifecycle management. Advise on national submission matters and any specific additional national requirements, identify deficiencies requiring resolution. Prepare gap analyses of UK documentation vs. EU and global requirements. Provide launch support and advise on supply questions of medicinal products to patients. Maintain licences of approved products, initiate and supervise implementation of changes; provide oversight and ensure regulatory compliance. Keep the European headquarters informed about the status of submissions and implementation of changes. Independently manage coordination and preparation of regulatory documents for UK submission, review regulatory and related documents for sign off prior to submission. This includes any national documents required for submission and for labelling and artwork implementation. Act as the regulatory liaison for the Daiichi Sankyo UK affiliate for a designated product range (and/or UK alliance partners). Act as the primary contact person for regulatory information and support. This includes Brand Teams, Medical, Market Access and Supply. Where required, support regulatory activities and submissions in Ireland, e.g. as absence cover. Work with the European Regulatory Team and Clinical Research Organisations to provide regulatory advice on matters related to interventional and non-interventional clinical trials in the UK if needed. Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives with particular focus on UK/MHRA national regulations. Communicate important changes and trends within Regulatory Affairs and UK affiliate business functions when relevant. Represent Regulatory Affairs and/or DS in internal and external interactions and liaise with functional groups at UK Affiliate, multidisciplinary local and multinational project and working teams, licence partners, authorities, and industry associations. Build up strong relationship with internal and external stakeholders at the UK affiliate and EU head office. Where applicable, mentor/instruct and provide guidance to internal and external reports including consultants and service providers. Plan, assign and direct work; manage competing priorities as appropriate. Lead or support projects to enhance the functionality and improve processes of the organisation and/or to adapt to a regulatory environment. Design and revise SOPs and SOIs if required. Contribute to continuous process improvements and inspection readiness for both internal process reviews/audits and HA inspections for GxP. Technical/Professional Knowledge: Degree in Pharmacy, Medicine, Life or Natural Sciences. Deep knowledge of UK/MHRA national laws, regulations, guidelines and other requirements for human medicinal product marketing authorisation and maintenance is essential. Significant level of experience (circa +5-8) years professional background in pharmaceutical industry, in Clinical Research Organisations or at a regulatory authority with +5 years proven experience in Regulatory Affairs with an emphasis on regulatory pre-submission and post-approval activities and preparation of new marketing authorisations in the UK and EU. Understanding of development and life-cycle management of drugs and regulatory processes including the regulatory requirements and processes in the UK and Europe. Ability to interact and communicate effectively with regulatory authorities and external stakeholders. Working experience with MHRA. Very high ethical standards. Excellent interpersonal skills. Ability to communicate and work across functions effectively in a multinational organisation to accomplish results. Be detail-oriented, well organised and self-motivated. Proven ability to plan, coordinate and lead activities simultaneously on multiple projects. Computer proficiency (e.g. MS office, document management systems, databases), excellent written and verbal communication skills in English. PhD, post-doctorate or professional experience in pre-clinical research or clinical development, a TOPRA diploma or Master's degree in Regulatory Affairs or other relevant specialisation. Experience in Oncology, including Project Orbis. Fluent in another European language. Why work with us? Working at Daiichi Sankyo is more than just a job - it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
Precision for Medicine are hiring a Processing Team Lead to join our well-established scientific team in Royston, UK who have been supporting biopharmaceutical research for over 25 years. Position Summary: The Processing Team Lead is responsible for receiving, inventory, shipment, and processing of biological samples into various components. Performing data reconciliation and assisting on an ongoing basis with organizing, planning, and prioritizing activities in the laboratory. Performance of competency assessments and line management of laboratory technicians. Ordering of lab supplies and the maintenance and validation of equipment. Essential functions of the job include but are not limited to: Sample Receipt and Processing: Organization and planning of sample processing activities and assist with prioritization of workload Ensure all incoming fresh biological samples are accessioned into BSI in an accurate and timely manner Perform cell isolations and/or separate whole blood and body fluids into various components following specific operating procedures Perform cryopreservation of isolated cells, and cell thawing and counting following specific operating procedures Coordinate ordering of lab supplies and maintain appropriate inventory levels PBMC process owner - responsible for sample processing documentation, equipment maintenance and validation, and staff training Effectively communicate all problems, concerns or incidents to Manager / Project Manager Proactively work to resolve sample discrepancies Data Reconciliation and QC: Perform data entry QC checks in BSI Investigate and resolve data discrepancies in electronic databases. Prepare and analyze reports from BSI to identify possible errors or check sample inventory Generate, protect, and maintain raw data, analyzed, reported data and associated metadata, including sample, reagent and methodology details Maintain accurate, up to date records (lab and timesheet) Maintain accurate, up to date metrics for the UK lab PBMC processing performance Training and Competency Assessment: Train and perform competency assessments of new PBMC processing team members Assist and train other team members in areas of own expertise Regulatory: Comply with all quality management, regulatory compliance, and project management processes (GxP, HTA, H&S). Work to the current Good Clinical Practice for Laboratories (GCLP) standards and maintain appropriate training and qualifications. Other: Respond to freezer alarms in accordance with standard operating procedure Carry out other duties/projects as assigned Ability to participate in On Call rota for out of hours work Actively participate in performance review and personal development processes required Qualifications and Experience: Level 5 qualification, HND in Biological sciences (or related discipline) or equivalent, with a minimum of 3 years' relevant laboratory experience Experience in the successful isolation of viable PBMCs from whole blood Preferred: BSc in Biological sciences (or a related discipline) or equivalent with a minimum of 2 years' relevant laboratory experience Well-developed laboratory skills and be trained in aseptic technique Experience working in a regulated environment (GLP, GCLP) Strong communication skills both verbal and written IT skills, particularly Microsoft tools. Experience working with sample management databases would be an advantage. Requires handling of fresh human biofluids and human primary cells May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC) HepB vaccination, proof of immunization or waiver is acceptable Personal Attributes: Team player but able to work on own initiative Organized, methodical and accurate Exceptional attention to detail Analytical, interpretation and problem solving skills Able to cope with pressure, and the ever changing needs of the business Honest and with obvious integrity Self starter - enthusiastic and energetic
Feb 18, 2025
Full time
Precision for Medicine are hiring a Processing Team Lead to join our well-established scientific team in Royston, UK who have been supporting biopharmaceutical research for over 25 years. Position Summary: The Processing Team Lead is responsible for receiving, inventory, shipment, and processing of biological samples into various components. Performing data reconciliation and assisting on an ongoing basis with organizing, planning, and prioritizing activities in the laboratory. Performance of competency assessments and line management of laboratory technicians. Ordering of lab supplies and the maintenance and validation of equipment. Essential functions of the job include but are not limited to: Sample Receipt and Processing: Organization and planning of sample processing activities and assist with prioritization of workload Ensure all incoming fresh biological samples are accessioned into BSI in an accurate and timely manner Perform cell isolations and/or separate whole blood and body fluids into various components following specific operating procedures Perform cryopreservation of isolated cells, and cell thawing and counting following specific operating procedures Coordinate ordering of lab supplies and maintain appropriate inventory levels PBMC process owner - responsible for sample processing documentation, equipment maintenance and validation, and staff training Effectively communicate all problems, concerns or incidents to Manager / Project Manager Proactively work to resolve sample discrepancies Data Reconciliation and QC: Perform data entry QC checks in BSI Investigate and resolve data discrepancies in electronic databases. Prepare and analyze reports from BSI to identify possible errors or check sample inventory Generate, protect, and maintain raw data, analyzed, reported data and associated metadata, including sample, reagent and methodology details Maintain accurate, up to date records (lab and timesheet) Maintain accurate, up to date metrics for the UK lab PBMC processing performance Training and Competency Assessment: Train and perform competency assessments of new PBMC processing team members Assist and train other team members in areas of own expertise Regulatory: Comply with all quality management, regulatory compliance, and project management processes (GxP, HTA, H&S). Work to the current Good Clinical Practice for Laboratories (GCLP) standards and maintain appropriate training and qualifications. Other: Respond to freezer alarms in accordance with standard operating procedure Carry out other duties/projects as assigned Ability to participate in On Call rota for out of hours work Actively participate in performance review and personal development processes required Qualifications and Experience: Level 5 qualification, HND in Biological sciences (or related discipline) or equivalent, with a minimum of 3 years' relevant laboratory experience Experience in the successful isolation of viable PBMCs from whole blood Preferred: BSc in Biological sciences (or a related discipline) or equivalent with a minimum of 2 years' relevant laboratory experience Well-developed laboratory skills and be trained in aseptic technique Experience working in a regulated environment (GLP, GCLP) Strong communication skills both verbal and written IT skills, particularly Microsoft tools. Experience working with sample management databases would be an advantage. Requires handling of fresh human biofluids and human primary cells May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC) HepB vaccination, proof of immunization or waiver is acceptable Personal Attributes: Team player but able to work on own initiative Organized, methodical and accurate Exceptional attention to detail Analytical, interpretation and problem solving skills Able to cope with pressure, and the ever changing needs of the business Honest and with obvious integrity Self starter - enthusiastic and energetic
Precision Medicine Group, LLC.
Royston, Hertfordshire
Location: Royston Hertfordshire UK Royston Hertfordshire UK Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5221 Precision for Medicine are hiring a Processing Team Lead to join our well-established scientific team in Royston, UK who have been supporting biopharmaceutical research for over 25 years. Position Summary The Processing Team Lead is responsible for receiving, inventory, shipment, and processing of biological samples into various components. Performing data reconciliation and assisting on an ongoing basis with organizing, planning, and prioritizing activities in the laboratory. Performance of competency assessments and line management of laboratory technicians. Ordering of lab supplies and the maintenance and validation of equipment. Essential functions of the job include but are not limited to: Sample Receipt and Processing: Organization and planning of sample processing activities and assist with prioritization of workload Ensure all incoming fresh biological samples are accessioned into BSI in an accurate and timely manner Perform cell isolations and/or separate whole blood and body fluids into various components following specific operating procedures Perform cryopreservation of isolated cells, and cell thawing and counting following specific operating procedures Coordinate ordering of lab supplies and maintain appropriate inventory levels PBMC process owner - responsible for sample processing documentation, equipment maintenance and validation, and staff training Effectively communicate all problems, concerns or incidents to Manager / Project Manager Proactively work to resolve sample discrepancies Data Reconciliation and QC: Perform data entry QC checks in BSI Investigate and resolve data discrepancies in electronic databases. Prepare and analyze reports from BSI to identify possible errors or check sample inventory Generate, protect, and maintain raw data, analyzed, reported data and associated metadata, including sample, reagent and methodology details Maintain accurate, up to date records (lab and timesheet) Maintain accurate, up to date metrics for the UK lab PBMC processing performance Training and Competency Assessment: Train and perform competency assessments of new PBMC processing team members Assist and train other team members in areas of own expertise Regulatory: Comply with all quality management, regulatory compliance, and project management processes (GxP, HTA, H&S). Work to the current Good Clinical Practice for Laboratories (GCLP) standards and maintain appropriate training and qualifications. Other: Respond to freezer alarms in accordance with standard operating procedure Carry out other duties/projects as assigned Ability to participate in On Call rota for out of hours work Actively participate in performance review and personal development processes required Qualifications and Experience: Level 5 qualification, HND in Biological sciences (or related discipline) or equivalent, with a minimum of 3 years' relevant laboratory experience Experience in the successful isolation of viable PBMCs from whole blood Preferred: BSc in Biological sciences (or a related discipline) or equivalent with a minimum of 2 years' relevant laboratory experience Well-developed laboratory skills and be trained in aseptic technique Experience working in a regulated environment (GLP, GCLP) Strong communication skills both verbal and written IT skills, particularly Microsoft tools. Experience working with sample management databases would be an advantage. Requires handling of fresh human biofluids and human primary cells May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC) HepB vaccination, proof of immunization or waiver is acceptable Personal Attributes: Team player but able to work on own initiative Organized, methodical and accurate Exceptional attention to detail Analytical, interpretation and problem solving skills Able to cope with pressure, and the ever-changing needs of the business Honest and with obvious integrity Self-starter - enthusiastic and energetic
Feb 16, 2025
Full time
Location: Royston Hertfordshire UK Royston Hertfordshire UK Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5221 Precision for Medicine are hiring a Processing Team Lead to join our well-established scientific team in Royston, UK who have been supporting biopharmaceutical research for over 25 years. Position Summary The Processing Team Lead is responsible for receiving, inventory, shipment, and processing of biological samples into various components. Performing data reconciliation and assisting on an ongoing basis with organizing, planning, and prioritizing activities in the laboratory. Performance of competency assessments and line management of laboratory technicians. Ordering of lab supplies and the maintenance and validation of equipment. Essential functions of the job include but are not limited to: Sample Receipt and Processing: Organization and planning of sample processing activities and assist with prioritization of workload Ensure all incoming fresh biological samples are accessioned into BSI in an accurate and timely manner Perform cell isolations and/or separate whole blood and body fluids into various components following specific operating procedures Perform cryopreservation of isolated cells, and cell thawing and counting following specific operating procedures Coordinate ordering of lab supplies and maintain appropriate inventory levels PBMC process owner - responsible for sample processing documentation, equipment maintenance and validation, and staff training Effectively communicate all problems, concerns or incidents to Manager / Project Manager Proactively work to resolve sample discrepancies Data Reconciliation and QC: Perform data entry QC checks in BSI Investigate and resolve data discrepancies in electronic databases. Prepare and analyze reports from BSI to identify possible errors or check sample inventory Generate, protect, and maintain raw data, analyzed, reported data and associated metadata, including sample, reagent and methodology details Maintain accurate, up to date records (lab and timesheet) Maintain accurate, up to date metrics for the UK lab PBMC processing performance Training and Competency Assessment: Train and perform competency assessments of new PBMC processing team members Assist and train other team members in areas of own expertise Regulatory: Comply with all quality management, regulatory compliance, and project management processes (GxP, HTA, H&S). Work to the current Good Clinical Practice for Laboratories (GCLP) standards and maintain appropriate training and qualifications. Other: Respond to freezer alarms in accordance with standard operating procedure Carry out other duties/projects as assigned Ability to participate in On Call rota for out of hours work Actively participate in performance review and personal development processes required Qualifications and Experience: Level 5 qualification, HND in Biological sciences (or related discipline) or equivalent, with a minimum of 3 years' relevant laboratory experience Experience in the successful isolation of viable PBMCs from whole blood Preferred: BSc in Biological sciences (or a related discipline) or equivalent with a minimum of 2 years' relevant laboratory experience Well-developed laboratory skills and be trained in aseptic technique Experience working in a regulated environment (GLP, GCLP) Strong communication skills both verbal and written IT skills, particularly Microsoft tools. Experience working with sample management databases would be an advantage. Requires handling of fresh human biofluids and human primary cells May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC) HepB vaccination, proof of immunization or waiver is acceptable Personal Attributes: Team player but able to work on own initiative Organized, methodical and accurate Exceptional attention to detail Analytical, interpretation and problem solving skills Able to cope with pressure, and the ever-changing needs of the business Honest and with obvious integrity Self-starter - enthusiastic and energetic
Senior Scientist I/II, Analytical Development and Validation We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you. We are currently recruiting for a Senior Scientist I/II to join the Analytical Development and Technology group. This role requires a seasoned professional to lead and manage analytical projects (CMC) encompassing assay development, qualification, validation, and QC implementation for testing lentiviral vectors for cell and gene therapies from early to late-stage clinical development. The successful candidate will support team members and ensure the timely and high-quality delivery of team goals and client work packages. Your responsibilities in this role would be: Lead the development, transfer, qualification, and validation of assays for testing lentiviral vectors to support characterization, release and stability testing (GMP). Manage and deliver client work packages, maintaining proactive coordination and communication with clients, internal project managers, AD team members and other departments, under supervision from Group Leads. Author and review technical documents, including qualification/validation plans, study documentation, reports, risk assessments and SOPs. Act as a Subject Matter Expert (SME) for analytical methods such as cell-based, qPCR/ddPCR, ELISA, and HPLC, providing scientific and technical guidance, troubleshooting, and contributing to client discussions. Contribute to regulatory documents for CMC analytical sections of clinical trial applications (IMPD, IND) and marketing authorizations (MAA, BLA), in accordance with ICH and regulatory agencies guidelines. Ensure robust technical transfer of methods to QC (Quality Control) and other departments/sites. Ensure a high standard of record keeping and documentation of experiments and investigations in order that information is clearly captured, disseminated and reported, from good research practices to GxP standards. Drive innovation in assay lifecycle management and contribute new ideas to enhance viral vector analysis within the team and organization. Contribute to continuous improvement projects to increase efficiency of the team activities. Support and mentor other scientists within the department. We are looking for: BSc, MSc or PhD in a Biosciences field or similar. Knowledge and laboratory experience in two or more of the following assay types: cell-based assays, qPCR/ddPCR, molecular biology, ELISA or HPLC. Experience in managing and delivering scientific/technical projects to defined objectives and timelines in a busy environment. Experience in liaising and communicating with different stakeholders such as adjacent teams/departments, external partners, clients or collaborators is an advantage. Experience in working or being exposed to a regulated GxP environment is strongly preferred. Knowledge/experience in virology and/or gene therapy products is an advantage. Understanding of basic statistics in experimental data analysis and/or AQbD/DOE. Competency in data capture, documenting and reporting scientific/technical studies. Ability to work accurately in a busy and demanding environment, and to manage competing priorities. Credible and confident communicator (written & verbal). Self-motivated with the ability to work proactively using own initiative. Demonstrates ability to work well in a team as well as independently. High level of familiarity with Microsoft Office.
Feb 13, 2025
Full time
Senior Scientist I/II, Analytical Development and Validation We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you. We are currently recruiting for a Senior Scientist I/II to join the Analytical Development and Technology group. This role requires a seasoned professional to lead and manage analytical projects (CMC) encompassing assay development, qualification, validation, and QC implementation for testing lentiviral vectors for cell and gene therapies from early to late-stage clinical development. The successful candidate will support team members and ensure the timely and high-quality delivery of team goals and client work packages. Your responsibilities in this role would be: Lead the development, transfer, qualification, and validation of assays for testing lentiviral vectors to support characterization, release and stability testing (GMP). Manage and deliver client work packages, maintaining proactive coordination and communication with clients, internal project managers, AD team members and other departments, under supervision from Group Leads. Author and review technical documents, including qualification/validation plans, study documentation, reports, risk assessments and SOPs. Act as a Subject Matter Expert (SME) for analytical methods such as cell-based, qPCR/ddPCR, ELISA, and HPLC, providing scientific and technical guidance, troubleshooting, and contributing to client discussions. Contribute to regulatory documents for CMC analytical sections of clinical trial applications (IMPD, IND) and marketing authorizations (MAA, BLA), in accordance with ICH and regulatory agencies guidelines. Ensure robust technical transfer of methods to QC (Quality Control) and other departments/sites. Ensure a high standard of record keeping and documentation of experiments and investigations in order that information is clearly captured, disseminated and reported, from good research practices to GxP standards. Drive innovation in assay lifecycle management and contribute new ideas to enhance viral vector analysis within the team and organization. Contribute to continuous improvement projects to increase efficiency of the team activities. Support and mentor other scientists within the department. We are looking for: BSc, MSc or PhD in a Biosciences field or similar. Knowledge and laboratory experience in two or more of the following assay types: cell-based assays, qPCR/ddPCR, molecular biology, ELISA or HPLC. Experience in managing and delivering scientific/technical projects to defined objectives and timelines in a busy environment. Experience in liaising and communicating with different stakeholders such as adjacent teams/departments, external partners, clients or collaborators is an advantage. Experience in working or being exposed to a regulated GxP environment is strongly preferred. Knowledge/experience in virology and/or gene therapy products is an advantage. Understanding of basic statistics in experimental data analysis and/or AQbD/DOE. Competency in data capture, documenting and reporting scientific/technical studies. Ability to work accurately in a busy and demanding environment, and to manage competing priorities. Credible and confident communicator (written & verbal). Self-motivated with the ability to work proactively using own initiative. Demonstrates ability to work well in a team as well as independently. High level of familiarity with Microsoft Office.
ABOUT US Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives. THE ROLE We are seeking a Research Scientist to join our Laboratory Services Department. In this role, you will be responsible for carrying out laboratory tasks related to bioanalysis and/or safety studies as outlined in Protocols, Standard Operating Procedures, Work Instructions, regulations, and guidelines, following the principles of GCP/GCLP in relation to laboratories and Clinical Trials. Your responsibilities may include sample receipt, preparation, and analysis, as well as associated data recording and processing, along with general laboratory duties related to consumables, apparatus, equipment, and facility management. You will be expected to perform all tasks in accordance with company standards for timeliness, quality, and cost, and collaborate closely with the Senior Scientists, Principal Scientists, and other team members. KEY ACCOUNTABILITIES Process samples (sample preparation) generated in clinical studies for routine assay procedures, including the preparation of associated chemicals, reagents, and solutions, all in line with Protocols, Standard Operating Procedures (SOPs) and Working Instructions (WI). Assist the Senior Scientist and/or Principal Scientist in activities related to sample analysis, recording all data in line with company expectations. Assist the Senior Scientist and/or Principal Scientist in activities related to method verification/validation in order to deliver fully validated assays with the support of the Senior Research Scientist and Principal Scientist. Carry out various general laboratory duties to ensure the efficient operation of the laboratory, such as sample management activities, solvent logs, database maintenance, and waste management. Perform or assist with the routine maintenance/calibration of instrumentation or equipment. Assist with or prepare the production of relevant documentation (protocols, procedures, validation/study reports, SOPs, CAPAs, file notes), helping to ensure documents are delivered to the client and archived within expected timeframes. Ensure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment. (i.e., GCP, EMA and FDA). Document procedures undertaken in a clear, accurate and contemporaneous manner and apply Quality Control (QC) procedures to ensure their accuracy in accordance with the principles of ALCOA+. Communicate the status of assigned work with the assigned Principal Scientist, Laboratory Project Manager, and other team members. Maintain personal training records to demonstrate competency. SKILLS REQUIRED Essential BSc in Science related degree or equivalent Experience of working in a laboratory environment Experience of working to written instructions Good organisation skills with the ability to prioritise work and work to tight deadlines Experience of using general laboratory equipment such as pipettes, centrifuges, and balances Proficient in using Microsoft Office for documenting, analysing, and reporting data Ability to document process followed accurately in a contemporaneous manner Desirable Analytical Science degree, ideally holding a BSc in Chemistry or Biochemistry Experience working in a regulated environment (MHRA GCP for labs) Strong attention to detail, proven ability to manage multiple sample analyses Familiarity with the setup and use of HPLC/LC-MS-MS and/or ELISA systems and/or Safety Study analytical equipment Previous experience working with LIMS systems Ability to document laboratory information to a GXP standard, including preparation of analytical reports Ability to perform quality control processes. WHY YOU SHOULD JOIN US Simbec-Orion is growing fast. To keep up with demand, we're looking for the best people, from all areas of clinical development, to join our team. We're dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it. With experts from all disciplines under the same roof, you'll work alongside some of the industry's best. So if you'd like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We're waiting to hear from you.
Jun 11, 2024
Full time
ABOUT US Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives. THE ROLE We are seeking a Research Scientist to join our Laboratory Services Department. In this role, you will be responsible for carrying out laboratory tasks related to bioanalysis and/or safety studies as outlined in Protocols, Standard Operating Procedures, Work Instructions, regulations, and guidelines, following the principles of GCP/GCLP in relation to laboratories and Clinical Trials. Your responsibilities may include sample receipt, preparation, and analysis, as well as associated data recording and processing, along with general laboratory duties related to consumables, apparatus, equipment, and facility management. You will be expected to perform all tasks in accordance with company standards for timeliness, quality, and cost, and collaborate closely with the Senior Scientists, Principal Scientists, and other team members. KEY ACCOUNTABILITIES Process samples (sample preparation) generated in clinical studies for routine assay procedures, including the preparation of associated chemicals, reagents, and solutions, all in line with Protocols, Standard Operating Procedures (SOPs) and Working Instructions (WI). Assist the Senior Scientist and/or Principal Scientist in activities related to sample analysis, recording all data in line with company expectations. Assist the Senior Scientist and/or Principal Scientist in activities related to method verification/validation in order to deliver fully validated assays with the support of the Senior Research Scientist and Principal Scientist. Carry out various general laboratory duties to ensure the efficient operation of the laboratory, such as sample management activities, solvent logs, database maintenance, and waste management. Perform or assist with the routine maintenance/calibration of instrumentation or equipment. Assist with or prepare the production of relevant documentation (protocols, procedures, validation/study reports, SOPs, CAPAs, file notes), helping to ensure documents are delivered to the client and archived within expected timeframes. Ensure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment. (i.e., GCP, EMA and FDA). Document procedures undertaken in a clear, accurate and contemporaneous manner and apply Quality Control (QC) procedures to ensure their accuracy in accordance with the principles of ALCOA+. Communicate the status of assigned work with the assigned Principal Scientist, Laboratory Project Manager, and other team members. Maintain personal training records to demonstrate competency. SKILLS REQUIRED Essential BSc in Science related degree or equivalent Experience of working in a laboratory environment Experience of working to written instructions Good organisation skills with the ability to prioritise work and work to tight deadlines Experience of using general laboratory equipment such as pipettes, centrifuges, and balances Proficient in using Microsoft Office for documenting, analysing, and reporting data Ability to document process followed accurately in a contemporaneous manner Desirable Analytical Science degree, ideally holding a BSc in Chemistry or Biochemistry Experience working in a regulated environment (MHRA GCP for labs) Strong attention to detail, proven ability to manage multiple sample analyses Familiarity with the setup and use of HPLC/LC-MS-MS and/or ELISA systems and/or Safety Study analytical equipment Previous experience working with LIMS systems Ability to document laboratory information to a GXP standard, including preparation of analytical reports Ability to perform quality control processes. WHY YOU SHOULD JOIN US Simbec-Orion is growing fast. To keep up with demand, we're looking for the best people, from all areas of clinical development, to join our team. We're dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it. With experts from all disciplines under the same roof, you'll work alongside some of the industry's best. So if you'd like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We're waiting to hear from you.
Technologist (Medical Device) Winsford I am currently recruiting for a Technologist to join a world leading independent developer and manufacturer based in Winsford. Role responsibilities: Reporting to the Sustaining Engineering Manager, you will be a key member of the team responsible for the implementation of new materials, processes, and product design changes that enhance performance, improve quality, ensure regulatory compliance, achieve cost reduction goals and/or maintain continuity of supply of advanced wound care medical device portfolio. To plan, execute and report on manufacturing trials using new materials, products, and processes. To plan, execute and report on routine and investigative laboratory testing. Adopt & influence adoption of high standards of GDP, GLP, GMP & Health & Safety in the laboratory, manufacturing areas and offices. To author and review technical documentation in line with project requirements and in accordance with all applicable medical device regulations (MDD, MDR, FDA, CRF Part 8.20., ISO 13485, GxP) To support change control and regulatory change submissions. Actively contribute to departmental meetings and forums and contribute to the systematic improvement of the department in a positive, pragmatic, and enthusiastic manner. To support NC's, CAPA's from a technical perspective, conducting root cause analysis using recognised problem-solving, and quality improvement tools and techniques. To support design control activities, including authoring, reviewing, and updating design inputs, outputs, design verification, design validation, design transfers, design reviews, as required. Role requirements: Educated to degree level in a scientific discipline or engineering related field Able to work collaboratively and effectively with colleagues Driven to achieve results Strong statistical and analytical skills Strong practical problem-solving skills Strong organisational and communication skills Good knowledge of H&S, Quality and Regulatory compliance requirements. Experience of working in the Medical Device Industry in a technical capacity is preferable.
Dec 08, 2022
Full time
Technologist (Medical Device) Winsford I am currently recruiting for a Technologist to join a world leading independent developer and manufacturer based in Winsford. Role responsibilities: Reporting to the Sustaining Engineering Manager, you will be a key member of the team responsible for the implementation of new materials, processes, and product design changes that enhance performance, improve quality, ensure regulatory compliance, achieve cost reduction goals and/or maintain continuity of supply of advanced wound care medical device portfolio. To plan, execute and report on manufacturing trials using new materials, products, and processes. To plan, execute and report on routine and investigative laboratory testing. Adopt & influence adoption of high standards of GDP, GLP, GMP & Health & Safety in the laboratory, manufacturing areas and offices. To author and review technical documentation in line with project requirements and in accordance with all applicable medical device regulations (MDD, MDR, FDA, CRF Part 8.20., ISO 13485, GxP) To support change control and regulatory change submissions. Actively contribute to departmental meetings and forums and contribute to the systematic improvement of the department in a positive, pragmatic, and enthusiastic manner. To support NC's, CAPA's from a technical perspective, conducting root cause analysis using recognised problem-solving, and quality improvement tools and techniques. To support design control activities, including authoring, reviewing, and updating design inputs, outputs, design verification, design validation, design transfers, design reviews, as required. Role requirements: Educated to degree level in a scientific discipline or engineering related field Able to work collaboratively and effectively with colleagues Driven to achieve results Strong statistical and analytical skills Strong practical problem-solving skills Strong organisational and communication skills Good knowledge of H&S, Quality and Regulatory compliance requirements. Experience of working in the Medical Device Industry in a technical capacity is preferable.
Site Name: UK - Hertfordshire - Stevenage Posted Date: Sep We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Find out more: Our approach to R&D Investigator (Senior Bioanalyst/Associate Principal Scientist) (Immunoassay: Bioanalysis & Biomarkers) We are seeking a motivated and experienced Bioanalyst to join our group based at our flagship R&D site in Stevenage, Hertfordshire. The team supports pharmacokinetic (PK) and soluble biomarker measurements for clinical studies using a variety of ligand binding assay techniques. The data we generate is critical to helping GSK Project Teams make decisions on progressing new molecules towards becoming medicines. In this role you will independently develop and validate bespoke immunoassays for soluble biomarker and PK endpoints in support of clinical studies. You will be responsible for the delivery of high-quality large molecule bioanalytical assay data to study teams for early stage clinical studies (e.g. enabling and FTiH). You will also be required to act as a subject matter expert in support of our CRO partners, working to ensure that assay transfers proceed smoothly prior to later stage clinical studies. In this role you will Provide scientific leadership and set strategic direction on emerging technologies Build effective relationships with the various supported groups within and outside the department to balance stakeholder expectations with scientific quality and validation requirements ensuring limitations of assays and data are well understood Hold yourself accountable for delivering high quality bioanalytical results, managing timelines whilst being fully compliant with GCP regulatory requirements Adopt a technology agnostic attitude and openness to analytical techniques when planning support for all modalities Work as part of the team to ensure day-to-day laboratory responsibilities are met (reviewing study plans/reports etc) Drive the departments "automation first" objective for both the laboratory work and the pre-analytical and post-analytical workflows Partner with external companies, institutes and consortium to deliver solutions Well-connected in the analytical community established through publications and presentations at national and international conferences Drive innovation and actively contribute to process improvements (scientific, regulatory/quality) Closing Date for Applications: 6th October (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process. LI-GSK Why you? Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Graduate degree in biology, biochemistry or pharmacology Extensive experience running Bioanalytical or Biomarker studies in a GxP regulated environment with a focus on good record keeping and data integrity Experience in the method development and validation of quantitative immunoassays using one or more of the following Gyrolab, MSD, Simoa, SMCxPRO (or Erenna) Ability to effectively manage multiple priorities, communicate recommendations clearly and enjoy working within a team Ability to present both written and oral communications to R&D stakeholders Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: PhD degree in biology, biochemistry or pharmacology Understanding of regulatory aspects of human biological sample management, Good Clinical Practice (GCP) Experience of interacting with LabQA/regulatory inspectors Experience in tailoring bespoke biomarker assay validations to the context of use for the data Experience with automated liquid handling platforms (e.g. Labcyte Echo, SPT Labtech DragonFly, Agilent BRAVO, Hamilton STAR) Thorough understanding of the drug development process Experience using Thermo Watson LIMS Why GSK? Uniting science, technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing.So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more: Annual Report 2021 GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class ( US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.You can either call us on , or send an email As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK..... click apply for full job details
Sep 24, 2022
Full time
Site Name: UK - Hertfordshire - Stevenage Posted Date: Sep We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Find out more: Our approach to R&D Investigator (Senior Bioanalyst/Associate Principal Scientist) (Immunoassay: Bioanalysis & Biomarkers) We are seeking a motivated and experienced Bioanalyst to join our group based at our flagship R&D site in Stevenage, Hertfordshire. The team supports pharmacokinetic (PK) and soluble biomarker measurements for clinical studies using a variety of ligand binding assay techniques. The data we generate is critical to helping GSK Project Teams make decisions on progressing new molecules towards becoming medicines. In this role you will independently develop and validate bespoke immunoassays for soluble biomarker and PK endpoints in support of clinical studies. You will be responsible for the delivery of high-quality large molecule bioanalytical assay data to study teams for early stage clinical studies (e.g. enabling and FTiH). You will also be required to act as a subject matter expert in support of our CRO partners, working to ensure that assay transfers proceed smoothly prior to later stage clinical studies. In this role you will Provide scientific leadership and set strategic direction on emerging technologies Build effective relationships with the various supported groups within and outside the department to balance stakeholder expectations with scientific quality and validation requirements ensuring limitations of assays and data are well understood Hold yourself accountable for delivering high quality bioanalytical results, managing timelines whilst being fully compliant with GCP regulatory requirements Adopt a technology agnostic attitude and openness to analytical techniques when planning support for all modalities Work as part of the team to ensure day-to-day laboratory responsibilities are met (reviewing study plans/reports etc) Drive the departments "automation first" objective for both the laboratory work and the pre-analytical and post-analytical workflows Partner with external companies, institutes and consortium to deliver solutions Well-connected in the analytical community established through publications and presentations at national and international conferences Drive innovation and actively contribute to process improvements (scientific, regulatory/quality) Closing Date for Applications: 6th October (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process. LI-GSK Why you? Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Graduate degree in biology, biochemistry or pharmacology Extensive experience running Bioanalytical or Biomarker studies in a GxP regulated environment with a focus on good record keeping and data integrity Experience in the method development and validation of quantitative immunoassays using one or more of the following Gyrolab, MSD, Simoa, SMCxPRO (or Erenna) Ability to effectively manage multiple priorities, communicate recommendations clearly and enjoy working within a team Ability to present both written and oral communications to R&D stakeholders Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: PhD degree in biology, biochemistry or pharmacology Understanding of regulatory aspects of human biological sample management, Good Clinical Practice (GCP) Experience of interacting with LabQA/regulatory inspectors Experience in tailoring bespoke biomarker assay validations to the context of use for the data Experience with automated liquid handling platforms (e.g. Labcyte Echo, SPT Labtech DragonFly, Agilent BRAVO, Hamilton STAR) Thorough understanding of the drug development process Experience using Thermo Watson LIMS Why GSK? Uniting science, technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing.So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more: Annual Report 2021 GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class ( US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.You can either call us on , or send an email As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK..... click apply for full job details
Site Name: UK - London - Brentford, Belgium-Wavre, Canada - Ontario - Mississauga, Canada - Quebec - Laval, Home Worker - GBR, Home Worker - NLD, Netherlands - Amsterdam, UK - Hertfordshire - Stevenage, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Jun Once GSK were a traditional SAS programming group, today, we're a modern, innovative, agile function powered by multilingual coders, data engineers and data scientists who are all conversant in the latest approaches, capabilities and technologies. We're proud of our adoption of R and our leadership of open-source coding collaborations across the Pharma industry. Beyond this, we're investing in a new modern data science and analytics platform that will allow us to surface and analyse every kind of clinical and non-clinical data using the latest in programming methodologies and languages. We have career opportunities across a range of experience levels from junior programmers to industry experienced programmers and leaders to support multiple business areas. Join us to help people do more, feel better, live longer. What do we do? GSK is one of the world's foremost pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development with a global footprint spanning the UK, US, EU, Canada and India. GSK's speed and success in discovering and developing new medicines, therapies and vaccines is increasingly decided by scientific data and the effectiveness with which it can be captured, interrogated and understood. It's our job in Statistical Programming to equip our scientific experts with data that is seamlessly curated, analysed and visualised. We support every stage of the path that each potential drug progresses along, from non-clinical research to commercial launch and lifecycle management. How do we do it? We are transforming and becoming a modern, innovative, agile function powered by multilingual coders, data engineers and data scientists who are all conversant in the latest approaches, capabilities and technologies. We're proud of our adoption of R and our leadership of open-source coding collaborations across the Pharma industry. We are investing in a new statistical computing environment, a multimillion-pound modern data science and analytics platform that will allow us to surface and analyse every kind of clinical and non-clinical data using the latest in programming methodologies and languages (R, Python, SAS). Built-in automations will eliminate heavy manual and repetitive tasks and reduce cycle times from weeks to days. Additional initiatives include exploring machine learning to drive efficiencies for clinical reporting, developing desktop visualisation capabilities and we even have an annual challenge for Programmers who are rewarded for bringing new innovations into the department. What can we offer you? The data we deal with is increasingly complex and diverse, demanding a pioneering programming and analytics environment and a workforce who are continuously expanding their technical skills and looking for ways to innovate and experiment. Beyond the satisfaction of varied and interesting work in support of a really worthwhile mission, we will grow and develop you as an individual contributor and a potential leader in the field. And we don't just invest in your technical competencies and capabilities. Communication, influencing and management skills as well as the ability to work in an agile and collaborative way are also important attributes of outstanding programmers and data specialists. Great results and high performers are rewarded, but also we're a team with real camaraderie who care about each other and enjoy working together. Would you like a progressive career at the leading edge of transformation and innovation? Come and join our diverse global team of programmers and data scientists as we unlock the power of automation, analytics and visualisations to accelerate delivery of medicines and vaccines. Patients around the world are counting on us." GSK is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer. Oncology Programming is committed to develop novel Oncology therapies; support Data Strategy and Disease Area Strategy; and contribute to Medical and Market Access efforts. Current GSK Oncology portfolio consists of four key therapy areas: Immuno-Oncology, Oncology Cell & Gene Therapy, Synthetic Lethality, and Tumour Cell Targeting. HIV Clinical Programming excels at delivery in supporting ViiV Healthcare's mission to end the HIV epidemic and make sure no one living with HIV and AIDS is left behind. Innovative and scientifically curious, we pride ourselves on our collaboration with Clinical Statistics and wider team stakeholders . This is an exciting time to join this dynamic and cohesive team, working with a range of exciting programming platforms, to provide an emerging range of effective treatment options for our patients. US Hiring Locations: Collegeville, PA and Waltham, MA Canada Hiring Locations: Mississauga UK Hiring Locations: Stevenage, GSK House EU Hiring Locations: Netherlands, Belgium Remote Working: A variety of flexible working arrangements are available Key Responsibilities Principal Programmer/Lead - To lead and act as SME in your area Provide technical contribution to complex tasks Participate/Lead the planning and execution of multiple programming activities to deliver all required outputs Work as a lead within own discipline to investigate new technology as directed Act as a subject matter expert within own discipline Initiate new directions and novel strategies to achieve department goals Project manage or lead programming activities, including approval of plans under supervision, to achieve technical or business outcomes within own discipline Contribute to and influence the strategic planning and direction of a project Project manage and lead programming activities, including approval of plans under supervision, to achieve technical or business outcomes within own discipline Programmer - to work within a team towards projects and to develop your own career Automation of data creation, graphs, tables and certain statistical analyses using R scripts Effectively explains technical concepts to non-technical colleagues Apply learning from previous activities to result in quicker and more efficient completion of the current task Share learnings with peers and contributes to internal technical discussions/forums Active member of external professional/ industry organization Ensure the collection of programs/outputs and issues are adequately managed for programming activities to achieve business outcomes Contributes to and influences the strategic planning and direction of a project Demonstrated knowledge of and experience in the application of CDISC data and standards When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: BSc (or higher) in mathematics, statistics, computer science (or related discipline) Experience in R, SAS programming, and script/macro code development Working knowledge of relevant therapeutic area or industry to GSK projects such as oncology or clinical trials Preferred Qualifications (varies on level applied for) If you have the following characteristics, it would be a plus: MSc (or higher) in mathematics, statistics, computer science (or related discipline) Experience with programming language(s) Experience leading multiple studies Experience with writing and applying Metadata Specifications/Derivations Experience with products such as R-Shiny, Python, JMP, SAS/GRAPH, SAS Output Delivery System Knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable) Takes responsibility for oversight of others work as assigned by manager Demonstrated effectiveness in both oral and written communications, able to express ideas and incorporate feedback to produce a completed quality deliverable Able to explain technical approaches to peers and non-technical colleagues/settings..... click apply for full job details
Sep 23, 2022
Full time
Site Name: UK - London - Brentford, Belgium-Wavre, Canada - Ontario - Mississauga, Canada - Quebec - Laval, Home Worker - GBR, Home Worker - NLD, Netherlands - Amsterdam, UK - Hertfordshire - Stevenage, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Jun Once GSK were a traditional SAS programming group, today, we're a modern, innovative, agile function powered by multilingual coders, data engineers and data scientists who are all conversant in the latest approaches, capabilities and technologies. We're proud of our adoption of R and our leadership of open-source coding collaborations across the Pharma industry. Beyond this, we're investing in a new modern data science and analytics platform that will allow us to surface and analyse every kind of clinical and non-clinical data using the latest in programming methodologies and languages. We have career opportunities across a range of experience levels from junior programmers to industry experienced programmers and leaders to support multiple business areas. Join us to help people do more, feel better, live longer. What do we do? GSK is one of the world's foremost pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development with a global footprint spanning the UK, US, EU, Canada and India. GSK's speed and success in discovering and developing new medicines, therapies and vaccines is increasingly decided by scientific data and the effectiveness with which it can be captured, interrogated and understood. It's our job in Statistical Programming to equip our scientific experts with data that is seamlessly curated, analysed and visualised. We support every stage of the path that each potential drug progresses along, from non-clinical research to commercial launch and lifecycle management. How do we do it? We are transforming and becoming a modern, innovative, agile function powered by multilingual coders, data engineers and data scientists who are all conversant in the latest approaches, capabilities and technologies. We're proud of our adoption of R and our leadership of open-source coding collaborations across the Pharma industry. We are investing in a new statistical computing environment, a multimillion-pound modern data science and analytics platform that will allow us to surface and analyse every kind of clinical and non-clinical data using the latest in programming methodologies and languages (R, Python, SAS). Built-in automations will eliminate heavy manual and repetitive tasks and reduce cycle times from weeks to days. Additional initiatives include exploring machine learning to drive efficiencies for clinical reporting, developing desktop visualisation capabilities and we even have an annual challenge for Programmers who are rewarded for bringing new innovations into the department. What can we offer you? The data we deal with is increasingly complex and diverse, demanding a pioneering programming and analytics environment and a workforce who are continuously expanding their technical skills and looking for ways to innovate and experiment. Beyond the satisfaction of varied and interesting work in support of a really worthwhile mission, we will grow and develop you as an individual contributor and a potential leader in the field. And we don't just invest in your technical competencies and capabilities. Communication, influencing and management skills as well as the ability to work in an agile and collaborative way are also important attributes of outstanding programmers and data specialists. Great results and high performers are rewarded, but also we're a team with real camaraderie who care about each other and enjoy working together. Would you like a progressive career at the leading edge of transformation and innovation? Come and join our diverse global team of programmers and data scientists as we unlock the power of automation, analytics and visualisations to accelerate delivery of medicines and vaccines. Patients around the world are counting on us." GSK is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer. Oncology Programming is committed to develop novel Oncology therapies; support Data Strategy and Disease Area Strategy; and contribute to Medical and Market Access efforts. Current GSK Oncology portfolio consists of four key therapy areas: Immuno-Oncology, Oncology Cell & Gene Therapy, Synthetic Lethality, and Tumour Cell Targeting. HIV Clinical Programming excels at delivery in supporting ViiV Healthcare's mission to end the HIV epidemic and make sure no one living with HIV and AIDS is left behind. Innovative and scientifically curious, we pride ourselves on our collaboration with Clinical Statistics and wider team stakeholders . This is an exciting time to join this dynamic and cohesive team, working with a range of exciting programming platforms, to provide an emerging range of effective treatment options for our patients. US Hiring Locations: Collegeville, PA and Waltham, MA Canada Hiring Locations: Mississauga UK Hiring Locations: Stevenage, GSK House EU Hiring Locations: Netherlands, Belgium Remote Working: A variety of flexible working arrangements are available Key Responsibilities Principal Programmer/Lead - To lead and act as SME in your area Provide technical contribution to complex tasks Participate/Lead the planning and execution of multiple programming activities to deliver all required outputs Work as a lead within own discipline to investigate new technology as directed Act as a subject matter expert within own discipline Initiate new directions and novel strategies to achieve department goals Project manage or lead programming activities, including approval of plans under supervision, to achieve technical or business outcomes within own discipline Contribute to and influence the strategic planning and direction of a project Project manage and lead programming activities, including approval of plans under supervision, to achieve technical or business outcomes within own discipline Programmer - to work within a team towards projects and to develop your own career Automation of data creation, graphs, tables and certain statistical analyses using R scripts Effectively explains technical concepts to non-technical colleagues Apply learning from previous activities to result in quicker and more efficient completion of the current task Share learnings with peers and contributes to internal technical discussions/forums Active member of external professional/ industry organization Ensure the collection of programs/outputs and issues are adequately managed for programming activities to achieve business outcomes Contributes to and influences the strategic planning and direction of a project Demonstrated knowledge of and experience in the application of CDISC data and standards When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact . This will help us to understand any modifications we may need to make to support you throughout our selection process. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: BSc (or higher) in mathematics, statistics, computer science (or related discipline) Experience in R, SAS programming, and script/macro code development Working knowledge of relevant therapeutic area or industry to GSK projects such as oncology or clinical trials Preferred Qualifications (varies on level applied for) If you have the following characteristics, it would be a plus: MSc (or higher) in mathematics, statistics, computer science (or related discipline) Experience with programming language(s) Experience leading multiple studies Experience with writing and applying Metadata Specifications/Derivations Experience with products such as R-Shiny, Python, JMP, SAS/GRAPH, SAS Output Delivery System Knowledge of GxP, ICH requirements, internal processes and external regulations that govern drug development (where applicable) Takes responsibility for oversight of others work as assigned by manager Demonstrated effectiveness in both oral and written communications, able to express ideas and incorporate feedback to produce a completed quality deliverable Able to explain technical approaches to peers and non-technical colleagues/settings..... click apply for full job details
Owlstone Medical s mission is to save 100,000 lives and $1.5 billion in healthcare costs. We want to change the way we currently diagnose and monitor serious disease; our vision is to become the global leader in the non-invasive detection of cancer, infectious disease, and inflammatory disease. As we develop our technology and detection capability, we are continually evolving the requirements of our Quality Management System within the business. We are therefore looking for a QA Officer to support the Quality Team Lead with the compliance of our QMS - Currently ISO9001:2015, specifically for OML s diagnostics development. Key Tasks / Accountabilities Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes. Work with the Program/Project/ Department Managers and their teams to maintain all aspects of the QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint. Provide support as required for notified bodies and client audits, as well as performing internal audits according to schedule. Perform desk-based, remote and on-site audits of sub-contractors and suppliers. Working with other QA staff, provide support to departments, e.g. report review and QA statements, as well as assisting in training of personnel on matters relating to the QMS. Maintain thorough knowledge and understanding of ISO standards requirements, regulatory expectations and guidance documents relevant to the work performed within the program. Support Quality department initiatives as required, as part of a multi-disciplinary team. Requirements Education and Training Degree level qualification within Life Sciences (or equivalent) Competencies / Requirements Essential Planning and Organising Self-Motivated and able to work independently when required Strong presentation, communication and influencing skills Pragmatic with a flexible approach and the ability to deal with changing priorities Ability to work in a dynamic environment Experience and Knowledge Suitable working knowledge within a Pharmaceutical/Medical Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, Essential: ISO 13485, ISO17025 Desirable: experience of FDA regulations and ICH requirements Desirable: experience of auditing Suppliers to ISO13485 Desirable: Regulatory experience including post market surveillance Experience of an Electronic Document Management System Experience of using an Electronic Quality Management System (ideally Q-Pulse) Experience in using Excel and PowerPoint Skills Good inter-personal and communication skills Good organisational and time management skills
Sep 23, 2022
Full time
Owlstone Medical s mission is to save 100,000 lives and $1.5 billion in healthcare costs. We want to change the way we currently diagnose and monitor serious disease; our vision is to become the global leader in the non-invasive detection of cancer, infectious disease, and inflammatory disease. As we develop our technology and detection capability, we are continually evolving the requirements of our Quality Management System within the business. We are therefore looking for a QA Officer to support the Quality Team Lead with the compliance of our QMS - Currently ISO9001:2015, specifically for OML s diagnostics development. Key Tasks / Accountabilities Support continuous improvements in the Quality Management System (QMS) and maintain compliance of Quality processes. Work with the Program/Project/ Department Managers and their teams to maintain all aspects of the QMS as we develop our diagnostic capability e.g. Change Controls, Non-Conformities, CAPAs, Customer Complaint. Provide support as required for notified bodies and client audits, as well as performing internal audits according to schedule. Perform desk-based, remote and on-site audits of sub-contractors and suppliers. Working with other QA staff, provide support to departments, e.g. report review and QA statements, as well as assisting in training of personnel on matters relating to the QMS. Maintain thorough knowledge and understanding of ISO standards requirements, regulatory expectations and guidance documents relevant to the work performed within the program. Support Quality department initiatives as required, as part of a multi-disciplinary team. Requirements Education and Training Degree level qualification within Life Sciences (or equivalent) Competencies / Requirements Essential Planning and Organising Self-Motivated and able to work independently when required Strong presentation, communication and influencing skills Pragmatic with a flexible approach and the ability to deal with changing priorities Ability to work in a dynamic environment Experience and Knowledge Suitable working knowledge within a Pharmaceutical/Medical Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, Essential: ISO 13485, ISO17025 Desirable: experience of FDA regulations and ICH requirements Desirable: experience of auditing Suppliers to ISO13485 Desirable: Regulatory experience including post market surveillance Experience of an Electronic Document Management System Experience of using an Electronic Quality Management System (ideally Q-Pulse) Experience in using Excel and PowerPoint Skills Good inter-personal and communication skills Good organisational and time management skills
Simbec Orion Group Ltd
Merthyr Tydfil, Mid Glamorgan
ABOUT US Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below. Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives. THE ROLE We are looking for a Laboratory Quality Systems Associate to join our Laboratory Services team where you work with the Laboratory Quality Systems Lead to ensure the effectiveness and maintenance of the Laboratory Quality Management System. In addition, you will be responsible for ensuring that all documentation is accurate and reflects the work and testing required by the sponsor protocol for all studies being run by Simbec-Orion's Laboratory Services. You will help to promote a culture of continuous quality improvement at Simbec-Orion. KEY ACCOUNTABILITIES Ensure that work performed adheres to good practice regulations and guidelines. Document all procedures that are undertaken in a clear, accurate and contemporaneous manner and apply Quality Control (QC) procedures to ensure their accuracy. Serve as a key part of the Laboratory Services quality management structure, liaising with the other Laboratory Services managers and Laboratory employees to ensure successful delivery of customer projects. Support with updates and roll-out of new SOP's/Work instructions related to quality and subsequent training of all employees within Laboratory Services with quality associated training requirements. Support the ISO17025 compliance program and Quality improvements within the Laboratories. Support the Laboratory to ensure that work carried out meets GxP and GCP for Laboratories. Assist with Internal audits. Maintain personal training records to demonstrate competency and ensure compliance with audits. SKILLS REQUIRED ESSENTIAL Science degree or equivalent High level of attention to detail Excellent computer skills within O365 programs such as Word and Excel Ability to work in line with standard operating procedures and work instructions Ability to generate and maintain effective working relationships with team members and managers Ability to work in a fast-paced environment Strong interpersonal, communication, organisational and time management skills Ability to handle multiple tasks at one given time DESIRABLE Previous experience of working within a Clinical Research Organisation Previous experience working in a regulated environment (IS0 or MHRA GCP) WHY YOU SHOULD JOIN US Simbec-Orion is growing fast. To keep up with demand, we're looking for the best people, from all areas of clinical development, to join our team. We're dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it. With experts from all disciplines under the same roof, you'll work alongside some of the industry's best. So if you'd like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We're waiting to hear from you.
Sep 23, 2022
Full time
ABOUT US Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below. Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives. THE ROLE We are looking for a Laboratory Quality Systems Associate to join our Laboratory Services team where you work with the Laboratory Quality Systems Lead to ensure the effectiveness and maintenance of the Laboratory Quality Management System. In addition, you will be responsible for ensuring that all documentation is accurate and reflects the work and testing required by the sponsor protocol for all studies being run by Simbec-Orion's Laboratory Services. You will help to promote a culture of continuous quality improvement at Simbec-Orion. KEY ACCOUNTABILITIES Ensure that work performed adheres to good practice regulations and guidelines. Document all procedures that are undertaken in a clear, accurate and contemporaneous manner and apply Quality Control (QC) procedures to ensure their accuracy. Serve as a key part of the Laboratory Services quality management structure, liaising with the other Laboratory Services managers and Laboratory employees to ensure successful delivery of customer projects. Support with updates and roll-out of new SOP's/Work instructions related to quality and subsequent training of all employees within Laboratory Services with quality associated training requirements. Support the ISO17025 compliance program and Quality improvements within the Laboratories. Support the Laboratory to ensure that work carried out meets GxP and GCP for Laboratories. Assist with Internal audits. Maintain personal training records to demonstrate competency and ensure compliance with audits. SKILLS REQUIRED ESSENTIAL Science degree or equivalent High level of attention to detail Excellent computer skills within O365 programs such as Word and Excel Ability to work in line with standard operating procedures and work instructions Ability to generate and maintain effective working relationships with team members and managers Ability to work in a fast-paced environment Strong interpersonal, communication, organisational and time management skills Ability to handle multiple tasks at one given time DESIRABLE Previous experience of working within a Clinical Research Organisation Previous experience working in a regulated environment (IS0 or MHRA GCP) WHY YOU SHOULD JOIN US Simbec-Orion is growing fast. To keep up with demand, we're looking for the best people, from all areas of clinical development, to join our team. We're dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it. With experts from all disciplines under the same roof, you'll work alongside some of the industry's best. So if you'd like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We're waiting to hear from you.
Site Name: UK - Hertfordshire - Stevenage Posted Date: Sep 9 2022 Senior Quality Advisor - Qualified Person As a Senior Advisor of Cell & Gene Therapy you will be performing the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. This is a fantastic opportunity where you will be a Qualified Personas part of a growing team developing the systems and processed to support licensing of a new ATMP manufacturing facility. In the future working in a licensed facility to perform QP certification activities. You will be supporting inspection readiness and manufacturing campaign readiness, new product introduction and later support manufacturing operations, deviation investigations, change controls and internal audits and the addition of new products to our portfolio. Shift work will be required to meet the needs of the patients and the new manufacturing facility in 2023. In this role you will... Assure products meet regulatory requirements and that they conform to regulatory submissions. QP certification of drug product. Opportunity to be a part of the GSK QP community Interact with regulators as an SME. May participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues. May lead a project, program or team activities which may include GxP. Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions. Communicate and interact at various levels internally and externally to GSK. Build and maintain effective internal GSK business relationships within business units. Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D May be responsible for coaching, mentoring, training, or directing the activities on one or more direct reports. Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices. Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK. May represent the group as a primary business contact for specific areas. Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to Product Quality Pharma R&D and business units regionally and globally. Liaise with customers to provide compliance advice/input. Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments. Establish improvement processes, as needed, or set specific measurable targets and goals linked to GSK business needs. Closing Date for Applications: Friday 23rd July Please take a copy of the Job Description, as this will not be available post closure of the advert. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Bachelor of Science Degree (Chemistry, Pharmacy, Biology, or Related Science) Proven experience in the pharmaceutical industry related to Quality Assurance Previous experience in GMP manufacturing facility Laboratory experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree in scientific or relevant discipline: Master's Degree Able to makes decisions and communicating effectively as part of a team Resolves potential issues and drive solutions Analytical experience Facilitate working relations and processes that promote efficiencies and compliance in global and multidisciplinary environments Audit, Deviation investigation and Change control experience Highly organised, motivated and patient focused Experience in sterile manufacturing Eligible QP Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership ofgoals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class ( US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.You can either call us on , or send an email As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Sep 22, 2022
Full time
Site Name: UK - Hertfordshire - Stevenage Posted Date: Sep 9 2022 Senior Quality Advisor - Qualified Person As a Senior Advisor of Cell & Gene Therapy you will be performing the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. This is a fantastic opportunity where you will be a Qualified Personas part of a growing team developing the systems and processed to support licensing of a new ATMP manufacturing facility. In the future working in a licensed facility to perform QP certification activities. You will be supporting inspection readiness and manufacturing campaign readiness, new product introduction and later support manufacturing operations, deviation investigations, change controls and internal audits and the addition of new products to our portfolio. Shift work will be required to meet the needs of the patients and the new manufacturing facility in 2023. In this role you will... Assure products meet regulatory requirements and that they conform to regulatory submissions. QP certification of drug product. Opportunity to be a part of the GSK QP community Interact with regulators as an SME. May participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues. May lead a project, program or team activities which may include GxP. Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions. Communicate and interact at various levels internally and externally to GSK. Build and maintain effective internal GSK business relationships within business units. Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D May be responsible for coaching, mentoring, training, or directing the activities on one or more direct reports. Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices. Provide advice and consultancy to GSK project teams and external partners to reduce regulatory risk to GSK. May represent the group as a primary business contact for specific areas. Identify and mitigate compliance risks to GSK through effective assessments and/or via providing advice and consultancy to Product Quality Pharma R&D and business units regionally and globally. Liaise with customers to provide compliance advice/input. Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments. Establish improvement processes, as needed, or set specific measurable targets and goals linked to GSK business needs. Closing Date for Applications: Friday 23rd July Please take a copy of the Job Description, as this will not be available post closure of the advert. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Bachelor of Science Degree (Chemistry, Pharmacy, Biology, or Related Science) Proven experience in the pharmaceutical industry related to Quality Assurance Previous experience in GMP manufacturing facility Laboratory experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree in scientific or relevant discipline: Master's Degree Able to makes decisions and communicating effectively as part of a team Resolves potential issues and drive solutions Analytical experience Facilitate working relations and processes that promote efficiencies and compliance in global and multidisciplinary environments Audit, Deviation investigation and Change control experience Highly organised, motivated and patient focused Experience in sterile manufacturing Eligible QP Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership ofgoals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class ( US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.You can either call us on , or send an email As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it.Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
'Be You' at GSK At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us. As a , we empower you to be yourself, share ideas and work collaboratively Job Title Process Support Team Member Here at GSK, we are looking for a Process Support Team Member to join our talented team here in Barnard Castle. As a Process Support Team Member, you will be responsible for ensuring the Production/Warehouse areas are fully supported in terms of Compliance, Project, OE and NPI activity. You will provide the support required to be Audit Ready and fully compliant with Safety and Quality standards, while monitoring and issuing feedback on all Health and Safety, Quality and compliance systems. In this role you will... I Support NPI/capital projects as customers rep, including design development, factory acceptance testing, installation, validation, commissioning and associated documentation. Ensure Compliance with QMS/Group Quality Policies (G.Q.P.'s), EHS policies and Site Procedures. Ensure the area is continually in an audit ready state and fully compliant with Quality and Health and Safety Standards, support the area during audits. Complete actions arising from Audits, local improvement initiatives, project plans. Manage the completion of routines, Work Orders, PM's and new Routines. Raise and Manage Engineering Change Control (ECC's), Method Statements and staff briefing notes. Attend Quality/EHS meetings and present data / updates to area. Log and trend all compliance-based Quality and Safety subjects i.e. IPN's, ALE's, Document Errors. Review / Audit Line Clearance Risk Assessments. Ensure Validation certificates are correct, in place and within review. Change / update GXP parts reference manuals for Equipment Preparation / Manufacturing areas. Monitor, review and update procedures, Batch Documentation and Risk Assessments as required. Perform all aspects of PEL Administration including raising new PELs, revision of existing PELs and withdrawal of PELs from the system. Our Global Supply Chain (GSC) business is responsible for making and supplying our pharmaceutical and biopharmaceutical products around the globe. The GSC organisation is involved with every production stage from the infrastructure of the manufacturing sites, supply forecasting, regulatory inspections, and the product's quality. Why you? Qualifications & Skills: Experience working in an Admin focused role. Keen eye for detail and doing things the right way first time. Experienced following strict policies and procedures. Good eye for quality compliance and safety. SAP / M-ERP and VQD experience Preferred Qualifications & Skills: GCSE's or equivalent qualifications. COSHH / Noise / Lifting and Handling Assessor training. ZSC Divestment The ZSC Business has been sold to an external company. It is GSK's proposal to close its ZSC manufacturing operations once the technology transfer to the buyer is complete and the Manufacturing and Supply Agreement has come to an end. At this time, and in the absence of any other alternative, GSK would be proposing to close the ZSC sites. GSK would explore all options for retraining, supporting employees who might be at the risk of redundancy. During the expected 3-5 years duration, the successful candidate will be able to make a significant impact at ZSC and GSK. Whilst working at GSK you will be able to enjoy the excellent standard company benefits. You will also be able to utilise the ZSC Retraining and Development programme to identify and fund upskilling towards your future career ambition. In addition to this, there is an employee retention scheme which offers further financial bonuses for working within the business. As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on , or send an email As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Jun 01, 2022
Full time
'Be You' at GSK At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us. As a , we empower you to be yourself, share ideas and work collaboratively Job Title Process Support Team Member Here at GSK, we are looking for a Process Support Team Member to join our talented team here in Barnard Castle. As a Process Support Team Member, you will be responsible for ensuring the Production/Warehouse areas are fully supported in terms of Compliance, Project, OE and NPI activity. You will provide the support required to be Audit Ready and fully compliant with Safety and Quality standards, while monitoring and issuing feedback on all Health and Safety, Quality and compliance systems. In this role you will... I Support NPI/capital projects as customers rep, including design development, factory acceptance testing, installation, validation, commissioning and associated documentation. Ensure Compliance with QMS/Group Quality Policies (G.Q.P.'s), EHS policies and Site Procedures. Ensure the area is continually in an audit ready state and fully compliant with Quality and Health and Safety Standards, support the area during audits. Complete actions arising from Audits, local improvement initiatives, project plans. Manage the completion of routines, Work Orders, PM's and new Routines. Raise and Manage Engineering Change Control (ECC's), Method Statements and staff briefing notes. Attend Quality/EHS meetings and present data / updates to area. Log and trend all compliance-based Quality and Safety subjects i.e. IPN's, ALE's, Document Errors. Review / Audit Line Clearance Risk Assessments. Ensure Validation certificates are correct, in place and within review. Change / update GXP parts reference manuals for Equipment Preparation / Manufacturing areas. Monitor, review and update procedures, Batch Documentation and Risk Assessments as required. Perform all aspects of PEL Administration including raising new PELs, revision of existing PELs and withdrawal of PELs from the system. Our Global Supply Chain (GSC) business is responsible for making and supplying our pharmaceutical and biopharmaceutical products around the globe. The GSC organisation is involved with every production stage from the infrastructure of the manufacturing sites, supply forecasting, regulatory inspections, and the product's quality. Why you? Qualifications & Skills: Experience working in an Admin focused role. Keen eye for detail and doing things the right way first time. Experienced following strict policies and procedures. Good eye for quality compliance and safety. SAP / M-ERP and VQD experience Preferred Qualifications & Skills: GCSE's or equivalent qualifications. COSHH / Noise / Lifting and Handling Assessor training. ZSC Divestment The ZSC Business has been sold to an external company. It is GSK's proposal to close its ZSC manufacturing operations once the technology transfer to the buyer is complete and the Manufacturing and Supply Agreement has come to an end. At this time, and in the absence of any other alternative, GSK would be proposing to close the ZSC sites. GSK would explore all options for retraining, supporting employees who might be at the risk of redundancy. During the expected 3-5 years duration, the successful candidate will be able to make a significant impact at ZSC and GSK. Whilst working at GSK you will be able to enjoy the excellent standard company benefits. You will also be able to utilise the ZSC Retraining and Development programme to identify and fund upskilling towards your future career ambition. In addition to this, there is an employee retention scheme which offers further financial bonuses for working within the business. As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only). We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on , or send an email As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
Job Title: Pre-Sales Manager (Clinical Supplies) Location: Home-based, Europe preferred Salary: Competitive Position: Full Time, Permanent Travel Required: Yes, 50% expected across Europe & US About the role: This is an exciting position for candidates with a passion for business technology and process improvement. This role will support the Global Sales Team in growing our business within the Clinical Supply (Clinical Trial) sector. PRISYM ID's enterprise Label Lifecycle Management (LLM) solutions already enjoy a proven track record with many of the world's top Clinical Supply organisations, affording great reference ability. Job Duties: The role will involve working closely with the PRISYM ID Sales team and clients' subject matter experts from multiple departments including: operations, research & development, packaging & labelling, supply chain, procurement, manufacturing, regulatory and quality. Candidates will ideally have proven experience in a Pre-Sales role or have held a position in a consultative or operational capacity within the clinical supply chain. Responsibilities will include Assist the Sales team by technically qualifying new opportunities and by providing technical leadership throughout the sales process including leading customer discussions regarding business process improvement, solution architecture, systems validation (GxP) and implementation/migration strategies. Attend customer/prospect meetings to assist Sales identify demonstrable business value. Work with prospect and client stakeholders to evaluate and understand their business requirements. These are typically presented as RFI, RFP or URS (User Requirements Specification) documents which will be formally responded to. Build and deliver compelling customer-facing sales demonstrations and presentation of our solution offerings to provide customer education and assist with requirements analysis. Technical support to the Sales team to generate profitable business. Assist the sales team in the creation of sales quotations, estimates, proposal documents and Statement of Work (SoW) documents. Set agendas for and run customer-facing requirements workshops to identify current processes, required inputs and outputs, process improvements and mapping of content to the solution. Facilitating the handover between the Sales and Professional Service delivery teams for completed contracts. Work closely with the VP Global Product to stay current with product releases and to ensure that the Sales team have access to the latest tools to demonstrate to customers. Use of internal systems to provide weekly and monthly reporting for planning and forecasting. Pursue personal development skills and knowledge necessary for the effective performance of the role becoming a labelling solution subject matter expert within the Clinical Trials sector. About you: Required Communication Skills Professional written and verbal skills both internally and externally - must be confident talking to Business Users and Technologists alike Ability to gather customer needs accurately and relate these to the solution (product and services) offered Ability to build strong customer relationships Excellent communicator able to present complex technical concepts to a non-technical audience Required Technical Skills Ability to manage and co-ordinate complex RFI/RFP processes Experience of proposal writing and RFI/RFP responses Excellent knowledge of Microsoft Office Suite of products including Visio In depth knowledge of Cloud/SaaS and on-premise system architectures Understanding of web-based technologies and applications High level understanding of relational databases (SQL Server, Oracle) The ability to create and deliver technical presentations and demonstrations of an enterprise solution to a wide audience Ability to relate software features to business process benefits and vice versa Preferred Skills & Experience Experience of managing complex extended duration projects Previous experience of packaging and labeling within regulated industries Previous experience working for a company delivering global solutions Formal product or project management experience Knowledge of the Life Sciences (preferably Clinical Trials) market is a bonus as is understanding of computer system validation and FDA 21 CFR Part 11 The role is suitable for those looking to make a real-world and measurable difference to our organization - our collaboration with the world's leading Pharmaceutical and Clinical Supplies organisations will lead to ongoing improvement of patient health and patient safety. Please click the APPLY button to send your CV for this role. Candidates with previous experience and job titles of; Sales Team Leader, Sales Operations Manager, Sales Operations Analyst, Business Development Manager, Sales Support Manager will be considered for this role.
Dec 07, 2021
Full time
Job Title: Pre-Sales Manager (Clinical Supplies) Location: Home-based, Europe preferred Salary: Competitive Position: Full Time, Permanent Travel Required: Yes, 50% expected across Europe & US About the role: This is an exciting position for candidates with a passion for business technology and process improvement. This role will support the Global Sales Team in growing our business within the Clinical Supply (Clinical Trial) sector. PRISYM ID's enterprise Label Lifecycle Management (LLM) solutions already enjoy a proven track record with many of the world's top Clinical Supply organisations, affording great reference ability. Job Duties: The role will involve working closely with the PRISYM ID Sales team and clients' subject matter experts from multiple departments including: operations, research & development, packaging & labelling, supply chain, procurement, manufacturing, regulatory and quality. Candidates will ideally have proven experience in a Pre-Sales role or have held a position in a consultative or operational capacity within the clinical supply chain. Responsibilities will include Assist the Sales team by technically qualifying new opportunities and by providing technical leadership throughout the sales process including leading customer discussions regarding business process improvement, solution architecture, systems validation (GxP) and implementation/migration strategies. Attend customer/prospect meetings to assist Sales identify demonstrable business value. Work with prospect and client stakeholders to evaluate and understand their business requirements. These are typically presented as RFI, RFP or URS (User Requirements Specification) documents which will be formally responded to. Build and deliver compelling customer-facing sales demonstrations and presentation of our solution offerings to provide customer education and assist with requirements analysis. Technical support to the Sales team to generate profitable business. Assist the sales team in the creation of sales quotations, estimates, proposal documents and Statement of Work (SoW) documents. Set agendas for and run customer-facing requirements workshops to identify current processes, required inputs and outputs, process improvements and mapping of content to the solution. Facilitating the handover between the Sales and Professional Service delivery teams for completed contracts. Work closely with the VP Global Product to stay current with product releases and to ensure that the Sales team have access to the latest tools to demonstrate to customers. Use of internal systems to provide weekly and monthly reporting for planning and forecasting. Pursue personal development skills and knowledge necessary for the effective performance of the role becoming a labelling solution subject matter expert within the Clinical Trials sector. About you: Required Communication Skills Professional written and verbal skills both internally and externally - must be confident talking to Business Users and Technologists alike Ability to gather customer needs accurately and relate these to the solution (product and services) offered Ability to build strong customer relationships Excellent communicator able to present complex technical concepts to a non-technical audience Required Technical Skills Ability to manage and co-ordinate complex RFI/RFP processes Experience of proposal writing and RFI/RFP responses Excellent knowledge of Microsoft Office Suite of products including Visio In depth knowledge of Cloud/SaaS and on-premise system architectures Understanding of web-based technologies and applications High level understanding of relational databases (SQL Server, Oracle) The ability to create and deliver technical presentations and demonstrations of an enterprise solution to a wide audience Ability to relate software features to business process benefits and vice versa Preferred Skills & Experience Experience of managing complex extended duration projects Previous experience of packaging and labeling within regulated industries Previous experience working for a company delivering global solutions Formal product or project management experience Knowledge of the Life Sciences (preferably Clinical Trials) market is a bonus as is understanding of computer system validation and FDA 21 CFR Part 11 The role is suitable for those looking to make a real-world and measurable difference to our organization - our collaboration with the world's leading Pharmaceutical and Clinical Supplies organisations will lead to ongoing improvement of patient health and patient safety. Please click the APPLY button to send your CV for this role. Candidates with previous experience and job titles of; Sales Team Leader, Sales Operations Manager, Sales Operations Analyst, Business Development Manager, Sales Support Manager will be considered for this role.
* JOB SUMMARY * Assists and directs the customer-focused leadership and management of Regulatory Advice and Delivery Site Start-Up (RAD SSU) deliverables within the assigned projects or programs. Directs the technical and operational aspects of the RAD deliverables of the assigned projects. Accountable for the delivery of the post award early regulatory guidance and the regulatory impact assessment during study maintenance on time, on budget, and in compliance with all applicable regulations. Responsible for performing and overseeing core regulatory activities (such as core compilation and review of documents, and core submissions) related to submission from Site Start-Up activities until study end. Develops integrated RAD timelines and reports weekly progress including plans to address potential risks/gaps to the project team, Project Manager (PM), SSU Management and Project Sponsor. May act as the Regulatory Subject Matter Expert (SME) or as a mentor for less experienced staff. Assists senior RAD management for the SSU regulatory intelligence maintenance such as medical device and/or GMO regulation data mining in local country regulation, regulatory trainings support to the business departments. * JOB RESPONSIBLITIES * * Effectively manage the RAD resources including oversight of all project RAD deliverables which encompasses all activities from early post award regulatory guidance to study end * Develops new business opportunities whenever possible (e.g., while in attendance at professional conferences/seminars), participates in new business development activities including participation at client presentations. Reviews proposals, attends client sales-focused meetings, and provides information to support business development activities. Maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assess client needs. * Reviews the project RAD budget with the functional leads, project PM, and the SSU Business Unit Controller against SOW, project milestones and budget to ensure project profitability. Eventually takes corrective measures where necessary to keep project activities in line with budget and gross profit expectations. * Accountable in parallel to lead and provide adapted oversight regulatory activities for projects having high complex regulatory profile as Operational Regulatory Subject Matter Expert with major functional area leads (Project Management, and Clinical Management) * * * * Deliver overall RAD strategy driven by an operational risk management approach and status at client meetings and communicates outcomes to project team. Ensures all project deliverables meet the internal and customers' expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessment. * Develops and manages integrated RAD timelines and reports weekly progress including plans (to address potential timing risks/gaps or project regulatory KPI's) that track project's regulatory quality, delivery and predictability * * * * Monitor and ensure team's accountability, efficiency and adherence to project timelines. Ensure quality of designated deliverables. Responsible for driving team efficiencies with a goal of reducing waste and increasing RAD predictability. Accountable for individual utilization metrics. * * * * Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching. Identify skills and abilities that allow a regulatory professional to represent the function effectively as a member of a multi-disciplinary team. Support team with proposal development and client pitches (where applicable). * * Approves courses of action for staff members on salary administration, interviewing and selection, terminations, professional development, performance appraisals, position description preparation, and employee counseling * * * Pro-actively supports RAD intelligence strategies and communications * Identify and interpret laws, regulations, and guidance documents for domestic and international agencies relevant to the development and commercialisation of healthcare products. Identify new regulatory trends that could affect future requirements * Evaluate the global healthcare environment and its potential impact on the organisation. * Develop Regulatory Intelligence Programs on specific regulatory complex topics. Monitor team adherence for the timely follow-up for SSU operational Regulatory Intelligence Maintenance. Maintain current knowledge of applicable regulations and guidelines and direct implementation of training, as necessary. * Develop negotiation strategies with regulatory agencies and/or the regulated industry * Develop leadership skills and presentations that inspire high performance within the regulatory environment.at team or departmental review meetings. Have oversight of training programs for appropriate Syneos departmental teams. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately. and explain the importance of adapting to the changing regulatory environment * * * * Designated as subject matter expert in specific regulatory areas (e.g. pediatric studies, advanced therapy products, medical devices, etc.) to author and review Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes * Ensure personal compliance and/or accuracy with relevant quality standards. Consistently achieve and maintain utilization target and departmental goals * Maintains current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products * Explain the role of RAD professionals, their interrelationships with other functions in the organization and the importance of working as a team and operate effectively as a member of a multi-disciplinary team * Prioritise work to meet timelines and use a systematic approach to accomplish assigned tasks. *Other Responsibilities:* * Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management. * Ability to travel as required - approximatelly 40% * Minimum of a BA or BS * Minimum of seven (7) years' experience working in a Clinical Research environment with a minimum of five (5) years regulatory experience or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities do the job. Minimum of two (2) years of management experience * Subject matter expertise in current regulation frameworks (e.g. regulations and guidelines specific for non- interventional studies, clinical trial and medical device regulations) with extensive clinical trial experience * Experience in working to applicable GxPs (e.g GVP, GCP, ISO 14155) etc * Strong CRO operational experience with a track record in project management working in an international or global capacity. * Thorough knowledge of applicable regulations, drug development, and clinical project management procedures. * Previous experience in budgeting and quality management * Excellence communication and interpersonal skills, both written and spoken, with an ability to influence, convince and persuade * Strong leadership skills; ability to teach/mentor team members * Ability to recognize and take appropriate action when employee performance is not acceptable * Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet. * Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
Dec 06, 2021
Full time
* JOB SUMMARY * Assists and directs the customer-focused leadership and management of Regulatory Advice and Delivery Site Start-Up (RAD SSU) deliverables within the assigned projects or programs. Directs the technical and operational aspects of the RAD deliverables of the assigned projects. Accountable for the delivery of the post award early regulatory guidance and the regulatory impact assessment during study maintenance on time, on budget, and in compliance with all applicable regulations. Responsible for performing and overseeing core regulatory activities (such as core compilation and review of documents, and core submissions) related to submission from Site Start-Up activities until study end. Develops integrated RAD timelines and reports weekly progress including plans to address potential risks/gaps to the project team, Project Manager (PM), SSU Management and Project Sponsor. May act as the Regulatory Subject Matter Expert (SME) or as a mentor for less experienced staff. Assists senior RAD management for the SSU regulatory intelligence maintenance such as medical device and/or GMO regulation data mining in local country regulation, regulatory trainings support to the business departments. * JOB RESPONSIBLITIES * * Effectively manage the RAD resources including oversight of all project RAD deliverables which encompasses all activities from early post award regulatory guidance to study end * Develops new business opportunities whenever possible (e.g., while in attendance at professional conferences/seminars), participates in new business development activities including participation at client presentations. Reviews proposals, attends client sales-focused meetings, and provides information to support business development activities. Maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assess client needs. * Reviews the project RAD budget with the functional leads, project PM, and the SSU Business Unit Controller against SOW, project milestones and budget to ensure project profitability. Eventually takes corrective measures where necessary to keep project activities in line with budget and gross profit expectations. * Accountable in parallel to lead and provide adapted oversight regulatory activities for projects having high complex regulatory profile as Operational Regulatory Subject Matter Expert with major functional area leads (Project Management, and Clinical Management) * * * * Deliver overall RAD strategy driven by an operational risk management approach and status at client meetings and communicates outcomes to project team. Ensures all project deliverables meet the internal and customers' expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessment. * Develops and manages integrated RAD timelines and reports weekly progress including plans (to address potential timing risks/gaps or project regulatory KPI's) that track project's regulatory quality, delivery and predictability * * * * Monitor and ensure team's accountability, efficiency and adherence to project timelines. Ensure quality of designated deliverables. Responsible for driving team efficiencies with a goal of reducing waste and increasing RAD predictability. Accountable for individual utilization metrics. * * * * Oversee development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching. Identify skills and abilities that allow a regulatory professional to represent the function effectively as a member of a multi-disciplinary team. Support team with proposal development and client pitches (where applicable). * * Approves courses of action for staff members on salary administration, interviewing and selection, terminations, professional development, performance appraisals, position description preparation, and employee counseling * * * Pro-actively supports RAD intelligence strategies and communications * Identify and interpret laws, regulations, and guidance documents for domestic and international agencies relevant to the development and commercialisation of healthcare products. Identify new regulatory trends that could affect future requirements * Evaluate the global healthcare environment and its potential impact on the organisation. * Develop Regulatory Intelligence Programs on specific regulatory complex topics. Monitor team adherence for the timely follow-up for SSU operational Regulatory Intelligence Maintenance. Maintain current knowledge of applicable regulations and guidelines and direct implementation of training, as necessary. * Develop negotiation strategies with regulatory agencies and/or the regulated industry * Develop leadership skills and presentations that inspire high performance within the regulatory environment.at team or departmental review meetings. Have oversight of training programs for appropriate Syneos departmental teams. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately. and explain the importance of adapting to the changing regulatory environment * * * * Designated as subject matter expert in specific regulatory areas (e.g. pediatric studies, advanced therapy products, medical devices, etc.) to author and review Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes * Ensure personal compliance and/or accuracy with relevant quality standards. Consistently achieve and maintain utilization target and departmental goals * Maintains current knowledge of applicable regulations and guidelines. Identify relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products * Explain the role of RAD professionals, their interrelationships with other functions in the organization and the importance of working as a team and operate effectively as a member of a multi-disciplinary team * Prioritise work to meet timelines and use a systematic approach to accomplish assigned tasks. *Other Responsibilities:* * Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management. * Ability to travel as required - approximatelly 40% * Minimum of a BA or BS * Minimum of seven (7) years' experience working in a Clinical Research environment with a minimum of five (5) years regulatory experience or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities do the job. Minimum of two (2) years of management experience * Subject matter expertise in current regulation frameworks (e.g. regulations and guidelines specific for non- interventional studies, clinical trial and medical device regulations) with extensive clinical trial experience * Experience in working to applicable GxPs (e.g GVP, GCP, ISO 14155) etc * Strong CRO operational experience with a track record in project management working in an international or global capacity. * Thorough knowledge of applicable regulations, drug development, and clinical project management procedures. * Previous experience in budgeting and quality management * Excellence communication and interpersonal skills, both written and spoken, with an ability to influence, convince and persuade * Strong leadership skills; ability to teach/mentor team members * Ability to recognize and take appropriate action when employee performance is not acceptable * Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet. * Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
Job description: *Do you pride yourself on your integrity? We do what's right for employees, patients and partners, and so can you.* Oxford Biomedica's Quality Assurance (QA) team is responsible for the company's quality processes and systems, in compliance with GMP, GLP and GCP guidelines. The team are accountable for internal and external audits, quality compliance and control. We are currently recruiting for a Team Leader to manage a team of Senior QA officers and QA officers. The role will also require you to lead, co-ordinate and perform the day-to-day QA Operation activities and tasks, to meet the scheduled timelines in line with manufacturing and supporting function activities whilst ensuring regulatory compliance and industry expectations. *Your responsibilities in this role would be:* * Lead and be accountable for the performance of a team of Senior QA officers and QA officers. * Resource plan and maintain visibility of the team's workload, ensuring completion of activities assigned to direct reports to achieve team and business goals * Coordinates daily team workload & serves as first point of contact to other OXB departments/stakeholders * Reviewing / auditing documents generated during the Manufacturing, Quality Control, Engineering, Validation, Warehouse & Supply Chain GxP processes * Writing, reviewing and approving SOPs, Risk Assessments, Deviation, Change Control & CAPA records. * Proactively identifying improved ways of working within QA Operations & the wider QMS / PQS * Supporting Manufacturing, Quality Control, Engineering, Validation, Warehouse & Supply Chain teams by providing Quality Assurance input and guidance on regulatory requirements and industry expectations * Assuring compliance to EU and US FDA GxP, Company QMS and QA GMP Operations and any other applicable regulations / standards * Ensures that team's work complies with cGMP, Data Integrity & Good Documentation Practices * Assist in preparation of areas and QMS processes for inspections (Regulatory, Client and internal) * Participation in regulatory and client GMP audits and internal Self Inspection program * Participation in Client projects and programs * Providing Leadership, coaching, performance feedback and training to all direct reports * Back up/deputise for QA Operations Manager Profile description: *To be successful in this role, you will have the following skills and experience:* * Science based degree. * Substantial experience working in a pharmaceutical quality function * Experience of working within a Sterile / Aseptic GMP manufacturing environment is preferable. * Very good knowledge of the principles and guidelines for GMP/Regulatory requirements * Leadership and Management of small teams * The ability to lead, perform and train QA *processes.* * The ability to participate in Regulatory / Customer Audits. Experience with client interaction * Thorough understanding of equipment qualification and process validation. * Strong IT skills, including MS Office - Word, Explorer, Excel, Access, Outlook. * Thorough understanding of equipment qualification and process validation. *Do you want to feel inspired every day? We're future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.* *Collaborate. Contribute. Change lives* No Agencies please We offer: We are committed to offering highly competitive reward packages for all our staff. That's why, every year, we benchmark our salaries and benefits against the local pharmaceutical market - by that, we mean that we compare our packages with those of other major companies in the London, Oxford, Cambridge areas. We're looking for highly skilled, focused individuals to help us deliver life-changing therapies to patients. It's no mean feat, and we have to work together to make this happen. Along the way, you'll have a rich variety of opportunities to really develop your career. We'll also give you a generous set of employee benefits and a competitive salary.
Dec 03, 2021
Full time
Job description: *Do you pride yourself on your integrity? We do what's right for employees, patients and partners, and so can you.* Oxford Biomedica's Quality Assurance (QA) team is responsible for the company's quality processes and systems, in compliance with GMP, GLP and GCP guidelines. The team are accountable for internal and external audits, quality compliance and control. We are currently recruiting for a Team Leader to manage a team of Senior QA officers and QA officers. The role will also require you to lead, co-ordinate and perform the day-to-day QA Operation activities and tasks, to meet the scheduled timelines in line with manufacturing and supporting function activities whilst ensuring regulatory compliance and industry expectations. *Your responsibilities in this role would be:* * Lead and be accountable for the performance of a team of Senior QA officers and QA officers. * Resource plan and maintain visibility of the team's workload, ensuring completion of activities assigned to direct reports to achieve team and business goals * Coordinates daily team workload & serves as first point of contact to other OXB departments/stakeholders * Reviewing / auditing documents generated during the Manufacturing, Quality Control, Engineering, Validation, Warehouse & Supply Chain GxP processes * Writing, reviewing and approving SOPs, Risk Assessments, Deviation, Change Control & CAPA records. * Proactively identifying improved ways of working within QA Operations & the wider QMS / PQS * Supporting Manufacturing, Quality Control, Engineering, Validation, Warehouse & Supply Chain teams by providing Quality Assurance input and guidance on regulatory requirements and industry expectations * Assuring compliance to EU and US FDA GxP, Company QMS and QA GMP Operations and any other applicable regulations / standards * Ensures that team's work complies with cGMP, Data Integrity & Good Documentation Practices * Assist in preparation of areas and QMS processes for inspections (Regulatory, Client and internal) * Participation in regulatory and client GMP audits and internal Self Inspection program * Participation in Client projects and programs * Providing Leadership, coaching, performance feedback and training to all direct reports * Back up/deputise for QA Operations Manager Profile description: *To be successful in this role, you will have the following skills and experience:* * Science based degree. * Substantial experience working in a pharmaceutical quality function * Experience of working within a Sterile / Aseptic GMP manufacturing environment is preferable. * Very good knowledge of the principles and guidelines for GMP/Regulatory requirements * Leadership and Management of small teams * The ability to lead, perform and train QA *processes.* * The ability to participate in Regulatory / Customer Audits. Experience with client interaction * Thorough understanding of equipment qualification and process validation. * Strong IT skills, including MS Office - Word, Explorer, Excel, Access, Outlook. * Thorough understanding of equipment qualification and process validation. *Do you want to feel inspired every day? We're future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.* *Collaborate. Contribute. Change lives* No Agencies please We offer: We are committed to offering highly competitive reward packages for all our staff. That's why, every year, we benchmark our salaries and benefits against the local pharmaceutical market - by that, we mean that we compare our packages with those of other major companies in the London, Oxford, Cambridge areas. We're looking for highly skilled, focused individuals to help us deliver life-changing therapies to patients. It's no mean feat, and we have to work together to make this happen. Along the way, you'll have a rich variety of opportunities to really develop your career. We'll also give you a generous set of employee benefits and a competitive salary.
Simbec Orion Group Ltd
Merthyr Tydfil, Mid Glamorgan
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives. * Summary of the Position: * We are looking for a Senior Research Scientist to join our Laboratories department. You will be based in our offices in Merthyr Tydfil, UK. You will w ork on projects to analyse drugs, their metabolites and other analytes in biological fluids and pharmaceutical preparation . The role will be laboratory -focu sed, participating in the development, validation and subsequent LC-MS-MS analysis of samples generated from clinical trials, whilst maintaining meticulous, contemporaneous data recording. You will support with the supervision of Laboratory Services Scientist to ensure compliance with regulatory good practice and guidance requirements within set timeframes. * Key Accountabilities: * * * E nsure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment. (i.e., GCP , EMA and FDA requirements). * D ocument procedures undertaken in a clear, accurate and contemporaneous man ne r and apply Quality Control (QC) procedures to ensure their accuracy in accordance with the principles of ALCOA + . * * C ommunicate the status of work being performed with the assigned Principal Scientist , Laboratory Project Manager and other team members . * * D evelo p methods of analysis to deliver fully validated assays. * * S upervise/oversee or p repare chemicals, reagents , solutions and process samples generated in a clinical study for routine assay procedures as described in Standard Operating Procedures (SOPs ) and Working Instructions. * * Ensure that samples have been scheduled or run u sing Analyst software (including the use of LC-MS-MS techniques and/or review of chromatographic data ) . * * P erform routine maintenance/calibration of instrumentation or equipment. * * P roduce relevant documentation such as protocols, procedures, validation/study reports , SOP's , CAPA's , file notes. * * Provide technical advice to business development and participate in laboratory - related discussions with Sponsor s and Simbec -Orion employees . * * M aintain personal training records to demonstrate competency and support in the train ing and development of other Laboratory Services employees . * * Carry out various general laboratory duties in order to ensure the efficient operation of the laboratory (i.e., database maintenance , waste management , etc.). *Minimum Requirements:* *Essential:* * * BSc Science Degree * * Previous e xperience in working in a laboratory environment * Ability to develop and validate methods using LC-MS-MS * Good o rganisation s kills with the ability to prioritise work to meet deadlines * Good general laboratory skills , a bility to use general laboratory equipment such as pipettes, centrifuges, and balances * P roficient with Microsoft Office for documenting , analysing and reporting data * Ability to document laboratory information accurately in a contemporaneous manner * Good communication skills * Desirable: * * * BSc in Chemistry or related analytical degree * Previous experience in working in a regulated environment (MHRA GCP, GLP or GMP) * Strong attention to detail, proven ability of managing multiple sample analyses. * Previous experience of working with LIMS systems * Ability to document laboratory information to a GXP standard , including preparation of analytical reports * Ability to perform quality control processes * Track record of working within a team environment * Simbec Orion Job Profile - Senior Research Scientist.pdf * Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. *
Dec 03, 2021
Full time
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives. * Summary of the Position: * We are looking for a Senior Research Scientist to join our Laboratories department. You will be based in our offices in Merthyr Tydfil, UK. You will w ork on projects to analyse drugs, their metabolites and other analytes in biological fluids and pharmaceutical preparation . The role will be laboratory -focu sed, participating in the development, validation and subsequent LC-MS-MS analysis of samples generated from clinical trials, whilst maintaining meticulous, contemporaneous data recording. You will support with the supervision of Laboratory Services Scientist to ensure compliance with regulatory good practice and guidance requirements within set timeframes. * Key Accountabilities: * * * E nsure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment. (i.e., GCP , EMA and FDA requirements). * D ocument procedures undertaken in a clear, accurate and contemporaneous man ne r and apply Quality Control (QC) procedures to ensure their accuracy in accordance with the principles of ALCOA + . * * C ommunicate the status of work being performed with the assigned Principal Scientist , Laboratory Project Manager and other team members . * * D evelo p methods of analysis to deliver fully validated assays. * * S upervise/oversee or p repare chemicals, reagents , solutions and process samples generated in a clinical study for routine assay procedures as described in Standard Operating Procedures (SOPs ) and Working Instructions. * * Ensure that samples have been scheduled or run u sing Analyst software (including the use of LC-MS-MS techniques and/or review of chromatographic data ) . * * P erform routine maintenance/calibration of instrumentation or equipment. * * P roduce relevant documentation such as protocols, procedures, validation/study reports , SOP's , CAPA's , file notes. * * Provide technical advice to business development and participate in laboratory - related discussions with Sponsor s and Simbec -Orion employees . * * M aintain personal training records to demonstrate competency and support in the train ing and development of other Laboratory Services employees . * * Carry out various general laboratory duties in order to ensure the efficient operation of the laboratory (i.e., database maintenance , waste management , etc.). *Minimum Requirements:* *Essential:* * * BSc Science Degree * * Previous e xperience in working in a laboratory environment * Ability to develop and validate methods using LC-MS-MS * Good o rganisation s kills with the ability to prioritise work to meet deadlines * Good general laboratory skills , a bility to use general laboratory equipment such as pipettes, centrifuges, and balances * P roficient with Microsoft Office for documenting , analysing and reporting data * Ability to document laboratory information accurately in a contemporaneous manner * Good communication skills * Desirable: * * * BSc in Chemistry or related analytical degree * Previous experience in working in a regulated environment (MHRA GCP, GLP or GMP) * Strong attention to detail, proven ability of managing multiple sample analyses. * Previous experience of working with LIMS systems * Ability to document laboratory information to a GXP standard , including preparation of analytical reports * Ability to perform quality control processes * Track record of working within a team environment * Simbec Orion Job Profile - Senior Research Scientist.pdf * Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. *
My client, a pharma company based in Scotland, seek a GCP Specialist to join their friendly team. Reporting to the Head of QA, this person will assist with all aspects of clinical compliance and quality management activities including document review, internal systems review and oversight of external site and vendor audits and follow up. They will also review and assess quality metric trends e.g. from audits, to ensure that satisfactory CAPA plans are established. They will use their expertise to provide quality guidance to the company, ensuring that appropriate systems, processes and procedures are in place which comply with applicable regulations, and to study and company requirements. This is an immediate employment opportunity and could be either full-time or part-time. The office is in Aberdeen, so location or relocation to Aberdeen is preferred, but this role can be remote, with fortnightly trips to the office (travel costs expensed). *Key Responsibilities:* * Assist in implementing and maintaining a comprehensive GCP compliant quality programme. * Assist in setting the annual internal, vendor and project schedules. * Oversee or conduct document audits, internal system audits, vendor audits and investigator site audits to assess compliance with study protocols and cGxP, and act as QA audit manager for selected audits. * Oversee contract Auditors, providing first line of communication. * Manage CAPA plans and follow up via an appropriate system and/or database. * Oversee Quality Issue Management ensuring escalated issues are appropriately recorded, followed through to successful resolution and the outcomes reported. * Assist the Head of QA to coordinate Competent Authority facility GCP inspections of the company and provide assistance for other GxP Inspections. * Assist the Head of QA with the initiation, writing, review, approval, update and distribution of documents e.g. policies, SOPs and associated documents, to support the Company QMS. * Maintain awareness and integrate current and new GxP regulations and requirements into company systems, processes and procedures. * When requested by the Head of QA, assist with the review of vendor SOPs, to ensure consistency with regulatory and company requirements. * Provide routine and ad-hoc consultancy to company employees on all QA, GxP and Quality Management issues. * Prepare and conduct basic and focused GxP training, as requested by the Head of QA. * Provide feedback and suggestions for process improvement to ensure process efficiency and effectiveness. * Conduct all activities according to regulatory requirements, global guidelines and company policies and procedures. *Key Requirements:* * Degree in science, nursing or a life sciences degree or degree in Quality Management * Considerable pharmaceutical or allied industry experience (8 years minimum), including direct quality assurance or regulatory compliance experience. * Working knowledge of GCP/ICH, EMA and FDA regulations and guidelines and how these interface with other cGxPs * Commitment and ability to handle high workloads and deadlines * Knowledge of Drug Safety/Pharmacovigilance advantageous * Experience in working in a company with marketed products and IMPs advantageous * Regulatory inspection experience (hosting/participant/interviewee) advantageous. Personal Skills: * Team player with strong communication and negotiation skills * Ability to prioritise workload and commitment to meeting deadlines * Ability to make decisions, evaluate risks, propose innovative solutions, and define and execute action plans * Ability to work independently in an office or remote environment. My client offers a competitive salary, negotiable based on experience, excellent working conditions, and a fulfilling and rewarding career, with plenty of opportunities for further development. If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on 584300, or apply with your CV to arrange a confidential discussion.
Dec 01, 2021
Full time
My client, a pharma company based in Scotland, seek a GCP Specialist to join their friendly team. Reporting to the Head of QA, this person will assist with all aspects of clinical compliance and quality management activities including document review, internal systems review and oversight of external site and vendor audits and follow up. They will also review and assess quality metric trends e.g. from audits, to ensure that satisfactory CAPA plans are established. They will use their expertise to provide quality guidance to the company, ensuring that appropriate systems, processes and procedures are in place which comply with applicable regulations, and to study and company requirements. This is an immediate employment opportunity and could be either full-time or part-time. The office is in Aberdeen, so location or relocation to Aberdeen is preferred, but this role can be remote, with fortnightly trips to the office (travel costs expensed). *Key Responsibilities:* * Assist in implementing and maintaining a comprehensive GCP compliant quality programme. * Assist in setting the annual internal, vendor and project schedules. * Oversee or conduct document audits, internal system audits, vendor audits and investigator site audits to assess compliance with study protocols and cGxP, and act as QA audit manager for selected audits. * Oversee contract Auditors, providing first line of communication. * Manage CAPA plans and follow up via an appropriate system and/or database. * Oversee Quality Issue Management ensuring escalated issues are appropriately recorded, followed through to successful resolution and the outcomes reported. * Assist the Head of QA to coordinate Competent Authority facility GCP inspections of the company and provide assistance for other GxP Inspections. * Assist the Head of QA with the initiation, writing, review, approval, update and distribution of documents e.g. policies, SOPs and associated documents, to support the Company QMS. * Maintain awareness and integrate current and new GxP regulations and requirements into company systems, processes and procedures. * When requested by the Head of QA, assist with the review of vendor SOPs, to ensure consistency with regulatory and company requirements. * Provide routine and ad-hoc consultancy to company employees on all QA, GxP and Quality Management issues. * Prepare and conduct basic and focused GxP training, as requested by the Head of QA. * Provide feedback and suggestions for process improvement to ensure process efficiency and effectiveness. * Conduct all activities according to regulatory requirements, global guidelines and company policies and procedures. *Key Requirements:* * Degree in science, nursing or a life sciences degree or degree in Quality Management * Considerable pharmaceutical or allied industry experience (8 years minimum), including direct quality assurance or regulatory compliance experience. * Working knowledge of GCP/ICH, EMA and FDA regulations and guidelines and how these interface with other cGxPs * Commitment and ability to handle high workloads and deadlines * Knowledge of Drug Safety/Pharmacovigilance advantageous * Experience in working in a company with marketed products and IMPs advantageous * Regulatory inspection experience (hosting/participant/interviewee) advantageous. Personal Skills: * Team player with strong communication and negotiation skills * Ability to prioritise workload and commitment to meeting deadlines * Ability to make decisions, evaluate risks, propose innovative solutions, and define and execute action plans * Ability to work independently in an office or remote environment. My client offers a competitive salary, negotiable based on experience, excellent working conditions, and a fulfilling and rewarding career, with plenty of opportunities for further development. If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on 584300, or apply with your CV to arrange a confidential discussion.
Global Clinical Supply Chain Project Manager An opportunity has arisen for a Clinical Supply Chain PM to join a multinational pharmaceutical and biopharmaceutical company. Location: Macclesfield 1-2 days onsite per week Pay rate: 330 per day PAYE - 430 per day umbrella Duration: 12 months Role Summary: Accountable for the development and performance of clinical supply chains owning the E2E supply of products in the development portfolio. Be influential in the design phase with relevant experts to drive optimised design with respect to quality, risk and cost for the business Monitors the performance of the supply chain and optimise for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk. Leads the Supply Chain Team (SCT) which is accountable for developing and maintaining the supply plan for the project . Work in conjunction with the Supply Chain planner to guarantee: Balancing Short to Mid-term Supply and Demand, Inventory Management, input into D&OP Process, planning Excellence Process Requirements, SS Master Data Management. Overall endorsement of the supply plan is the CSCL accountability Accountable for a significant budget for supply activities and materials for the project. Maintain appropriate information for supply activities in PLANNIT on an ongoing basis and in line with RBU. Ensure ongoing supply through transition from development sources to commercial sources of manufacture. Manage change in demand and supply, resolve issues, escalating when appropriate. Understands and acts according to GxP and knows the impact it has on supply chain activities. Work with other CSSLs to resolve issues, share best practice and continually develop competence. Promote supply chain practice in PT&D and interfacing functions. Take responsibility for managing issues and making complex trade-offs with both internal and external stakeholders. This will require well developed conceptual and analytical thinking to make complex judgements and deliver innovative solutions. Act as a sponsor to support and manage the implementation of supply chain change and be the 1st point of contract for Senior Stakeholders within the organizations regarding your portfolio of products. Experience/ Qualifications Required: Education including a degree in a relative field In depth knowledge of clinical supply chains and drug development process. In depth knowledge of Clinical Development processes relevant to investigational products. Awareness of GXP Standards within a Clinical environment Demand management and forecasting experience In depth experience of project management and influencing and maangign business partner relatrionships Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products System interaction aptitude for using systems to process data Stakeholder management/engagement positioning and influencing Please apply by sending your CVs to
Dec 01, 2021
Full time
Global Clinical Supply Chain Project Manager An opportunity has arisen for a Clinical Supply Chain PM to join a multinational pharmaceutical and biopharmaceutical company. Location: Macclesfield 1-2 days onsite per week Pay rate: 330 per day PAYE - 430 per day umbrella Duration: 12 months Role Summary: Accountable for the development and performance of clinical supply chains owning the E2E supply of products in the development portfolio. Be influential in the design phase with relevant experts to drive optimised design with respect to quality, risk and cost for the business Monitors the performance of the supply chain and optimise for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk. Leads the Supply Chain Team (SCT) which is accountable for developing and maintaining the supply plan for the project . Work in conjunction with the Supply Chain planner to guarantee: Balancing Short to Mid-term Supply and Demand, Inventory Management, input into D&OP Process, planning Excellence Process Requirements, SS Master Data Management. Overall endorsement of the supply plan is the CSCL accountability Accountable for a significant budget for supply activities and materials for the project. Maintain appropriate information for supply activities in PLANNIT on an ongoing basis and in line with RBU. Ensure ongoing supply through transition from development sources to commercial sources of manufacture. Manage change in demand and supply, resolve issues, escalating when appropriate. Understands and acts according to GxP and knows the impact it has on supply chain activities. Work with other CSSLs to resolve issues, share best practice and continually develop competence. Promote supply chain practice in PT&D and interfacing functions. Take responsibility for managing issues and making complex trade-offs with both internal and external stakeholders. This will require well developed conceptual and analytical thinking to make complex judgements and deliver innovative solutions. Act as a sponsor to support and manage the implementation of supply chain change and be the 1st point of contract for Senior Stakeholders within the organizations regarding your portfolio of products. Experience/ Qualifications Required: Education including a degree in a relative field In depth knowledge of clinical supply chains and drug development process. In depth knowledge of Clinical Development processes relevant to investigational products. Awareness of GXP Standards within a Clinical environment Demand management and forecasting experience In depth experience of project management and influencing and maangign business partner relatrionships Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products System interaction aptitude for using systems to process data Stakeholder management/engagement positioning and influencing Please apply by sending your CVs to
Global Clinical Supply Chain Project Manager An opportunity has arisen for a Clinical Supply Chain PM to join a multinational pharmaceutical and biopharmaceutical company. Location: Macclesfield 1-2 days onsite per week Pay rate: 330 per day PAYE - 430 per day umbrella Duration: 12 months Role Summary: Accountable for the development and performance of clinical supply chains owning the E2E supply of products in the development portfolio. Be influential in the design phase with relevant experts to drive optimised design with respect to quality, risk and cost for the business Monitors the performance of the supply chain and optimise for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk. Leads the Supply Chain Team (SCT) which is accountable for developing and maintaining the supply plan for the project . Work in conjunction with the Supply Chain planner to guarantee: Balancing Short to Mid-term Supply and Demand, Inventory Management, input into D&OP Process, planning Excellence Process Requirements, SS Master Data Management. Overall endorsement of the supply plan is the CSCL accountability Accountable for a significant budget for supply activities and materials for the project. Maintain appropriate information for supply activities in PLANNIT on an ongoing basis and in line with RBU. Ensure ongoing supply through transition from development sources to commercial sources of manufacture. Manage change in demand and supply, resolve issues, escalating when appropriate. Understands and acts according to GxP and knows the impact it has on supply chain activities. Work with other CSSLs to resolve issues, share best practice and continually develop competence. Promote supply chain practice in PT&D and interfacing functions. Take responsibility for managing issues and making complex trade-offs with both internal and external stakeholders. This will require well developed conceptual and analytical thinking to make complex judgements and deliver innovative solutions. Act as a sponsor to support and manage the implementation of supply chain change and be the 1st point of contract for Senior Stakeholders within the organizations regarding your portfolio of products. Experience/ Qualifications Required: Education including a degree in a relative field In depth knowledge of clinical supply chains and drug development process. In depth knowledge of Clinical Development processes relevant to investigational products. Awareness of GXP Standards within a Clinical environment Demand management and forecasting experience In depth experience of project management and influencing and maangign business partner relatrionships Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products System interaction aptitude for using systems to process data Stakeholder management/engagement positioning and influencing Please apply by sending your CVs to
Dec 01, 2021
Full time
Global Clinical Supply Chain Project Manager An opportunity has arisen for a Clinical Supply Chain PM to join a multinational pharmaceutical and biopharmaceutical company. Location: Macclesfield 1-2 days onsite per week Pay rate: 330 per day PAYE - 430 per day umbrella Duration: 12 months Role Summary: Accountable for the development and performance of clinical supply chains owning the E2E supply of products in the development portfolio. Be influential in the design phase with relevant experts to drive optimised design with respect to quality, risk and cost for the business Monitors the performance of the supply chain and optimise for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk. Leads the Supply Chain Team (SCT) which is accountable for developing and maintaining the supply plan for the project . Work in conjunction with the Supply Chain planner to guarantee: Balancing Short to Mid-term Supply and Demand, Inventory Management, input into D&OP Process, planning Excellence Process Requirements, SS Master Data Management. Overall endorsement of the supply plan is the CSCL accountability Accountable for a significant budget for supply activities and materials for the project. Maintain appropriate information for supply activities in PLANNIT on an ongoing basis and in line with RBU. Ensure ongoing supply through transition from development sources to commercial sources of manufacture. Manage change in demand and supply, resolve issues, escalating when appropriate. Understands and acts according to GxP and knows the impact it has on supply chain activities. Work with other CSSLs to resolve issues, share best practice and continually develop competence. Promote supply chain practice in PT&D and interfacing functions. Take responsibility for managing issues and making complex trade-offs with both internal and external stakeholders. This will require well developed conceptual and analytical thinking to make complex judgements and deliver innovative solutions. Act as a sponsor to support and manage the implementation of supply chain change and be the 1st point of contract for Senior Stakeholders within the organizations regarding your portfolio of products. Experience/ Qualifications Required: Education including a degree in a relative field In depth knowledge of clinical supply chains and drug development process. In depth knowledge of Clinical Development processes relevant to investigational products. Awareness of GXP Standards within a Clinical environment Demand management and forecasting experience In depth experience of project management and influencing and maangign business partner relatrionships Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products System interaction aptitude for using systems to process data Stakeholder management/engagement positioning and influencing Please apply by sending your CVs to
Global Clinical Supply Chain Project Manager An opportunity has arisen for a Clinical Supply Chain PM to join a multinational pharmaceutical and biopharmaceutical company. Location: Macclesfield 1-2 days onsite per week Pay rate: 330 per day PAYE - 430 per day umbrella Duration: 12 months Role Summary: Accountable for the development and performance of clinical supply chains owning the E2E supply of products in the development portfolio. Be influential in the design phase with relevant experts to drive optimised design with respect to quality, risk and cost for the business Monitors the performance of the supply chain and optimise for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk. Leads the Supply Chain Team (SCT) which is accountable for developing and maintaining the supply plan for the project . Work in conjunction with the Supply Chain planner to guarantee: Balancing Short to Mid-term Supply and Demand, Inventory Management, input into D&OP Process, planning Excellence Process Requirements, SS Master Data Management. Overall endorsement of the supply plan is the CSCL accountability Accountable for a significant budget for supply activities and materials for the project. Maintain appropriate information for supply activities in PLANNIT on an ongoing basis and in line with RBU. Ensure ongoing supply through transition from development sources to commercial sources of manufacture. Manage change in demand and supply, resolve issues, escalating when appropriate. Understands and acts according to GxP and knows the impact it has on supply chain activities. Work with other CSSLs to resolve issues, share best practice and continually develop competence. Promote supply chain practice in PT&D and interfacing functions. Take responsibility for managing issues and making complex trade-offs with both internal and external stakeholders. This will require well developed conceptual and analytical thinking to make complex judgements and deliver innovative solutions. Act as a sponsor to support and manage the implementation of supply chain change and be the 1st point of contract for Senior Stakeholders within the organizations regarding your portfolio of products. Experience/ Qualifications Required: Education including a degree in a relative field In depth knowledge of clinical supply chains and drug development process. In depth knowledge of Clinical Development processes relevant to investigational products. Awareness of GXP Standards within a Clinical environment Demand management and forecasting experience In depth experience of project management and influencing and maangign business partner relatrionships Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products System interaction aptitude for using systems to process data Stakeholder management/engagement positioning and influencing Please apply by sending your CVs to
Dec 01, 2021
Full time
Global Clinical Supply Chain Project Manager An opportunity has arisen for a Clinical Supply Chain PM to join a multinational pharmaceutical and biopharmaceutical company. Location: Macclesfield 1-2 days onsite per week Pay rate: 330 per day PAYE - 430 per day umbrella Duration: 12 months Role Summary: Accountable for the development and performance of clinical supply chains owning the E2E supply of products in the development portfolio. Be influential in the design phase with relevant experts to drive optimised design with respect to quality, risk and cost for the business Monitors the performance of the supply chain and optimise for higher volume phases of the project, balancing speed, quality and cost with respect to the agreed level of risk. Leads the Supply Chain Team (SCT) which is accountable for developing and maintaining the supply plan for the project . Work in conjunction with the Supply Chain planner to guarantee: Balancing Short to Mid-term Supply and Demand, Inventory Management, input into D&OP Process, planning Excellence Process Requirements, SS Master Data Management. Overall endorsement of the supply plan is the CSCL accountability Accountable for a significant budget for supply activities and materials for the project. Maintain appropriate information for supply activities in PLANNIT on an ongoing basis and in line with RBU. Ensure ongoing supply through transition from development sources to commercial sources of manufacture. Manage change in demand and supply, resolve issues, escalating when appropriate. Understands and acts according to GxP and knows the impact it has on supply chain activities. Work with other CSSLs to resolve issues, share best practice and continually develop competence. Promote supply chain practice in PT&D and interfacing functions. Take responsibility for managing issues and making complex trade-offs with both internal and external stakeholders. This will require well developed conceptual and analytical thinking to make complex judgements and deliver innovative solutions. Act as a sponsor to support and manage the implementation of supply chain change and be the 1st point of contract for Senior Stakeholders within the organizations regarding your portfolio of products. Experience/ Qualifications Required: Education including a degree in a relative field In depth knowledge of clinical supply chains and drug development process. In depth knowledge of Clinical Development processes relevant to investigational products. Awareness of GXP Standards within a Clinical environment Demand management and forecasting experience In depth experience of project management and influencing and maangign business partner relatrionships Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products System interaction aptitude for using systems to process data Stakeholder management/engagement positioning and influencing Please apply by sending your CVs to
