Bio-Techne
Bristol, Gloucestershire
Quality Assurance Officer (Product Release Team) page is loaded Quality Assurance Officer (Product Release Team) Apply remote type In-person locations Bristol, UK time type Full time posted on Posted 7 Days Ago job requisition id JR100991 By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. Job Title: Quality Assurance Officer (Product Release Team) Reports To: QA Team Leader - Product Release Team Location: Full On-site - Bristol, UK Contract type: Permanent Position Summary The Quality Assurance Officer, reporting to the Quality Assurance Team Leader, will join a vibrant and dynamic Quality Assurance team covering release activities relating to the development and manufacture of GMP, RMU and RUO products. The Quality Assurance Officer will help maintain the current Quality Systems to ISO 9001 and applicable GMP standards, as well as get involved in continual improvement of these systems. Essential Responsibilities Release Activities:Review, approval and release Batch Production Records related to GMP and RMU products. Review Quality Control testing data to disposition bulk product and retail lots for all product lines (RUO, RMU and GMP). Lead campaign reviews/product quality reviews for GMP manufacturing campaigns including minuting and follow-up activities. Supplier Quality:Complete QA approval of incoming raw materials used in GMP and RMU manufacturing. Cleanroom activities: Support manufacturing activities within ISO 7 and 8 cleanrooms, including conducting environmental monitoring of classified areas. Issue and review packaging and labelling documentation for lot creation. Inventory Management and Stock control: Involved in custody and storage of the GMP and RMU products (bulk product, retail lots and retained samples). Complete Shipping activities for GMP and RMU products. Equipment review: Review calibration, preventative maintenance reports for compliance with tolerances and internal procedures. Non-conformance:Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications. CAPA:Coordinate and approve/manage to completion any CAPA raised. Ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly. Documentation Management:Writing, reviewing, and approving internal procedures. Release and issuance of procedures and archiving previous revisions. Change Control:Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly. Training:Deliver in internal quality related training sessions. Internal Audits:Participation in the completion of the internal audit schedule.Conducting the internal audits, reporting any findings, and tracking completion of corrective actions. Technical Support:Providing technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations. Any other task as required by the business. Essential Qualifications BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field. A high level of experience working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company. Experience in a cGMP environment Proficiency with EudraLex Vol. 4 Part II or 21 CFR Part 820 Familiarity with ISO 9001 or ISO 13485 standards Experience in documentation management systems and change control processes from a Quality Assurance perspective. Demonstrates strong team-working skills, clear communication, and a positive, can-do attitude. Excels at prioritising tasks, manages time effectively, and maintains meticulous attention to detail. Flexible mindset with proven problem-solving ability and a willingness to tackle challenges head-on. Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture. Why Join Bio-Techne: We offer competitive wages along with extensive benefits for employees and their families. We invest in our employees' financial futures through retirement programs and an employee stock purchase plan. We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more. We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table. Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property. Similar Jobs (1) Quality Assurance Officer (Product Release Team) remote type In-person locations Bristol, UK time type Full time posted on Posted 30+ Days Ago
Quality Assurance Officer (Product Release Team) page is loaded Quality Assurance Officer (Product Release Team) Apply remote type In-person locations Bristol, UK time type Full time posted on Posted 7 Days Ago job requisition id JR100991 By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. Job Title: Quality Assurance Officer (Product Release Team) Reports To: QA Team Leader - Product Release Team Location: Full On-site - Bristol, UK Contract type: Permanent Position Summary The Quality Assurance Officer, reporting to the Quality Assurance Team Leader, will join a vibrant and dynamic Quality Assurance team covering release activities relating to the development and manufacture of GMP, RMU and RUO products. The Quality Assurance Officer will help maintain the current Quality Systems to ISO 9001 and applicable GMP standards, as well as get involved in continual improvement of these systems. Essential Responsibilities Release Activities:Review, approval and release Batch Production Records related to GMP and RMU products. Review Quality Control testing data to disposition bulk product and retail lots for all product lines (RUO, RMU and GMP). Lead campaign reviews/product quality reviews for GMP manufacturing campaigns including minuting and follow-up activities. Supplier Quality:Complete QA approval of incoming raw materials used in GMP and RMU manufacturing. Cleanroom activities: Support manufacturing activities within ISO 7 and 8 cleanrooms, including conducting environmental monitoring of classified areas. Issue and review packaging and labelling documentation for lot creation. Inventory Management and Stock control: Involved in custody and storage of the GMP and RMU products (bulk product, retail lots and retained samples). Complete Shipping activities for GMP and RMU products. Equipment review: Review calibration, preventative maintenance reports for compliance with tolerances and internal procedures. Non-conformance:Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications. CAPA:Coordinate and approve/manage to completion any CAPA raised. Ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly. Documentation Management:Writing, reviewing, and approving internal procedures. Release and issuance of procedures and archiving previous revisions. Change Control:Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly. Training:Deliver in internal quality related training sessions. Internal Audits:Participation in the completion of the internal audit schedule.Conducting the internal audits, reporting any findings, and tracking completion of corrective actions. Technical Support:Providing technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations. Any other task as required by the business. Essential Qualifications BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field. A high level of experience working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company. Experience in a cGMP environment Proficiency with EudraLex Vol. 4 Part II or 21 CFR Part 820 Familiarity with ISO 9001 or ISO 13485 standards Experience in documentation management systems and change control processes from a Quality Assurance perspective. Demonstrates strong team-working skills, clear communication, and a positive, can-do attitude. Excels at prioritising tasks, manages time effectively, and maintains meticulous attention to detail. Flexible mindset with proven problem-solving ability and a willingness to tackle challenges head-on. Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture. Why Join Bio-Techne: We offer competitive wages along with extensive benefits for employees and their families. We invest in our employees' financial futures through retirement programs and an employee stock purchase plan. We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more. We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table. Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property. Similar Jobs (1) Quality Assurance Officer (Product Release Team) remote type In-person locations Bristol, UK time type Full time posted on Posted 30+ Days Ago
Bio-Techne
Abingdon, Oxfordshire
Senior Director, Business Development - Licensing and Commercial Supply page is loaded Senior Director, Business Development - Licensing and Commercial Supply Apply remote type Fully remote locations Abingdon, UK DE - Remote FR - Massy Rennes, France Wisebaden, Germany time type Full time posted on Posted Yesterday job requisition id JR100951 By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. This position is fully remote and must have the ability to travel 50-70% of the time, including global travel. Position Summary: Bio-Techne is currently hiring for a Senior Director of Business Development for Licensing and Commercial Supply. This individual will be a pivotal leader in managing Bio-Techne's global licensing & OEM Business Development, with the goal of growing sales revenue through OEM and strategic supply partnerships. The ideal candidate will have experience building and scaling a global enterprise business development function, deep people leadership experience, and ability to influence and collaborate across multiple functions and levels within a highly matrixed, global organization. Key Responsibilities: Develop and scale an enterprise and global Business Development function for Bio-Techne's global licensing and OEM business, including development and execution of strategy, and people leadership of a global team Develop the strategy for significant, win-win OEM and licensing relationships leveraging Bio-Techne's enabling technologies, including prioritization of growth markets and target organizations. Analyze industry trends and strategic direction to better to better understand opportunities and competitors in the marketplace, with a strong focus on emerging technologies and applications. Create best-practice engagement models for licensing, supply agreements, and OEM including business terms, while partnering within the organization to develop term sheets, agreements and other standards to implement with current and future licensees/partners. Prospect, qualify, and develop relationships with new leads and existing customers to build pipeline and close new business in the Life Sciences and adjacent industries. As necessary to grow the business, plan for and hire additional team members to manage partnerships and to find new opportunities, while working within and across a larger matrixed commercial organization of sales and support personnel, to create reciprocal business opportunities. Develop relationships with customer champions and executive stakeholders on long-term, strategic, use-case roadmaps that provide opportunities capturing measurable value. Lead contract negotiations for net new business development activities to protect project margin while also securing trust with the customer. Collaborate internally with global marketing, product management and sales teams on selling strategies and product offerings to build and capture pipeline while delivering successful outcomes for all customers. Secure and nurture customer references to speak on behalf of Bio-Techne via testimonials, industry events, joint marketing activities, and prospect outreach. Education and Experience: Requires a Bachelor's Degree in Science 15+ years of progressive business development experience, especially in OEM and/or CRO/CDMO markets 10+ years of combined experience within the life sciences and diagnostics tools space 10+ years of progressive leadership and people management experience MS/PhD and relevant experience is preferred Prior experience building and scaling a global function is preferred Prior experience leading business development efforts in APAC is preferred Knowledge, Skills, and Abilities: Ability to influence and collaborate with executive leaders and leaders across various cross functions Customer Centric approach with the ability to anticipate customer needs Must have the ability to quickly learn the technical aspects of product lines across Bio-Techne businesses. Strong presentation skills demonstrating ability to communicate highly technical information clearly and effectively to a variety of different customer audiences Strong negotiation skills Ability to sell the value of a diverse and broad portfolio Experience working with Salesforce or other CRM Must demonstrate flexibility to work across the enterprise balancing the needs of multiple stakeholders internally while addressing the needs of the customer. Why Join Bio-Techne: We offer competitive wages along with extensive benefits for employees and their families. We invest in our employees' financial futures through retirement programs and an employee stock purchase plan. We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more. We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table. Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property. About Us Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.
Senior Director, Business Development - Licensing and Commercial Supply page is loaded Senior Director, Business Development - Licensing and Commercial Supply Apply remote type Fully remote locations Abingdon, UK DE - Remote FR - Massy Rennes, France Wisebaden, Germany time type Full time posted on Posted Yesterday job requisition id JR100951 By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. This position is fully remote and must have the ability to travel 50-70% of the time, including global travel. Position Summary: Bio-Techne is currently hiring for a Senior Director of Business Development for Licensing and Commercial Supply. This individual will be a pivotal leader in managing Bio-Techne's global licensing & OEM Business Development, with the goal of growing sales revenue through OEM and strategic supply partnerships. The ideal candidate will have experience building and scaling a global enterprise business development function, deep people leadership experience, and ability to influence and collaborate across multiple functions and levels within a highly matrixed, global organization. Key Responsibilities: Develop and scale an enterprise and global Business Development function for Bio-Techne's global licensing and OEM business, including development and execution of strategy, and people leadership of a global team Develop the strategy for significant, win-win OEM and licensing relationships leveraging Bio-Techne's enabling technologies, including prioritization of growth markets and target organizations. Analyze industry trends and strategic direction to better to better understand opportunities and competitors in the marketplace, with a strong focus on emerging technologies and applications. Create best-practice engagement models for licensing, supply agreements, and OEM including business terms, while partnering within the organization to develop term sheets, agreements and other standards to implement with current and future licensees/partners. Prospect, qualify, and develop relationships with new leads and existing customers to build pipeline and close new business in the Life Sciences and adjacent industries. As necessary to grow the business, plan for and hire additional team members to manage partnerships and to find new opportunities, while working within and across a larger matrixed commercial organization of sales and support personnel, to create reciprocal business opportunities. Develop relationships with customer champions and executive stakeholders on long-term, strategic, use-case roadmaps that provide opportunities capturing measurable value. Lead contract negotiations for net new business development activities to protect project margin while also securing trust with the customer. Collaborate internally with global marketing, product management and sales teams on selling strategies and product offerings to build and capture pipeline while delivering successful outcomes for all customers. Secure and nurture customer references to speak on behalf of Bio-Techne via testimonials, industry events, joint marketing activities, and prospect outreach. Education and Experience: Requires a Bachelor's Degree in Science 15+ years of progressive business development experience, especially in OEM and/or CRO/CDMO markets 10+ years of combined experience within the life sciences and diagnostics tools space 10+ years of progressive leadership and people management experience MS/PhD and relevant experience is preferred Prior experience building and scaling a global function is preferred Prior experience leading business development efforts in APAC is preferred Knowledge, Skills, and Abilities: Ability to influence and collaborate with executive leaders and leaders across various cross functions Customer Centric approach with the ability to anticipate customer needs Must have the ability to quickly learn the technical aspects of product lines across Bio-Techne businesses. Strong presentation skills demonstrating ability to communicate highly technical information clearly and effectively to a variety of different customer audiences Strong negotiation skills Ability to sell the value of a diverse and broad portfolio Experience working with Salesforce or other CRM Must demonstrate flexibility to work across the enterprise balancing the needs of multiple stakeholders internally while addressing the needs of the customer. Why Join Bio-Techne: We offer competitive wages along with extensive benefits for employees and their families. We invest in our employees' financial futures through retirement programs and an employee stock purchase plan. We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more. We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table. Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property. About Us Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.