Orchard Therapeutics plc.
Location: London Reporting to: Executive Director, Translational Research Job Summary Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts. This role is based in the heart of London in the Research facility of our Hammersmith headquarters. The Senior Research Technician will be responsible for oversight and management of technical activities relating to core lentiviral vector production and cell & gene therapy analytical methods for the Department of Translational Research. The role requires a deep expertise in molecular biology with applications to C>, with experience of viral vector production and characterisation, and related analytical methods, in order to lead activities for the provision of core technical services for the Translational Research team. Candidates should also have project and staff management experience to direct core technical staff, including scheduling and allocation of core activities, as well as providing line management, guidance, training and mentorship. The role will also include provision of laboratory oversight to support the Translational Research teams activities on ensuring compliance with policies, procedures and best practices for an organised and effective working environment to support and optimise productivity and quality of research. The Senior Research Technician will work closely with Translational Research Leadership to work towards continuous improvements in our core technical activities, research quality, data integrity and laboratory practices. Key Elements and Responsibilities: Senior Research Technician Senior administrative and laboratory technical role responsible for enabling and optimising daily operations of Orchard's core technical team to support the strategic goals of the Translational Research team. Provide line management of Translational Research Core Technical team, including allocation of assignments, training and development of technical staff. Oversee the coordination and processes of core Molecular Biology, Vector and Analytical activities provided for the Translational Research department, to align vector designs with production requirements, working with dedicated technical staff, and where required contribute directly to the delivery of: Vector Design & Assembly: Generating and validating novel lentiviral vectors for ex vivo or in vivo therapeutic applications, using expertise in molecular biology, CRISPR, PCR, qPCR, ddPCR, molecular cloning, western blotting, and mammalian cell culture. Production & Optimization: Producing lentivirus, optimising protocols and improving processes to provide high quality and consistent vector yields. Analytical Testing: Performing assays to assess viral titer, potency, transduction efficiency and purity, and developing standardized protocols for vector performance. Core LLV and Analytical Team Leadership: Providing expertise to support technical research staff, troubleshooting, updating protocols, and ensuring regulatory compliance. Implement rigorous experimental design, statistical analysis, and documentation to ensure reproducibility, traceability, and data integrity. Lead data integrity checks related to the Core technical teams activities, ensuring ELN records are completed with ALCOA+ principals. Contribute towards the authoring of nonclinical Reports submitted by the Translational Research team. Develop and implement lab workflows, SOPs and review Risk Assessments and best practices to support the Core LVV & Analytical teams scientific productivity, and drive continuous improvement activities, to oversee the achievement and maintenance of high-quality robust standards of research. Participation in Translational Research departmental meetings to share updates related to the Core Technical teams activities and provide updates on emerging and innovative technologies & platforms in C> Vector and Analytical methods. Provide compliance monitoring related to internal policies, guidelines and regulations governing laboratory activities to the Translational Research team. Act as a primary liaison for the Translational Research Team and Facilities Management Team to foster collaborative relationships between researchers and departments. Work closely with Benchling ELN Administrators to support continuous development of the ELN platform for Orchard's R&D activities including oversight of inventory management, data capture and data integrity. Any other duties allocated which fall within the general area of the position. Education / Key Competencies Experienced molecular/ cellular biologist with strong technical background and analytical abilities to support core technical research staff Being a team player with a 'can-do' attitude and problem-solving skills is a must, with experience of line management Organization, time and project management, prioritizing and the ability to handle a complex, varied workload Ability to work efficiently, both independently and as part of a team, with excellent communication, collaboration and influencing skills. Good computer skills, experience of working with an ELN such as Benchling is highly desirable Ability to deal diplomatically but firmly with difficult situations. Ability to operate in a fast-paced, multi-disciplinary industrial environment, with a customer service mindset Qualifications/ Experience Bachelor's or Master's degree in Biology, Life sciences, Biochemistry, Bioengineering, or cell and gene therapy related scientific field, with typically 8+ years of experience in laboratory operations, preferably within biotech or pharma research settings. Or PhD (or equivalent) in biological sciences or cell and gene therapy related scientific field with experience in laboratory operations, preferably within biotech or pharma research settings.
Location: London Reporting to: Executive Director, Translational Research Job Summary Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts. This role is based in the heart of London in the Research facility of our Hammersmith headquarters. The Senior Research Technician will be responsible for oversight and management of technical activities relating to core lentiviral vector production and cell & gene therapy analytical methods for the Department of Translational Research. The role requires a deep expertise in molecular biology with applications to C>, with experience of viral vector production and characterisation, and related analytical methods, in order to lead activities for the provision of core technical services for the Translational Research team. Candidates should also have project and staff management experience to direct core technical staff, including scheduling and allocation of core activities, as well as providing line management, guidance, training and mentorship. The role will also include provision of laboratory oversight to support the Translational Research teams activities on ensuring compliance with policies, procedures and best practices for an organised and effective working environment to support and optimise productivity and quality of research. The Senior Research Technician will work closely with Translational Research Leadership to work towards continuous improvements in our core technical activities, research quality, data integrity and laboratory practices. Key Elements and Responsibilities: Senior Research Technician Senior administrative and laboratory technical role responsible for enabling and optimising daily operations of Orchard's core technical team to support the strategic goals of the Translational Research team. Provide line management of Translational Research Core Technical team, including allocation of assignments, training and development of technical staff. Oversee the coordination and processes of core Molecular Biology, Vector and Analytical activities provided for the Translational Research department, to align vector designs with production requirements, working with dedicated technical staff, and where required contribute directly to the delivery of: Vector Design & Assembly: Generating and validating novel lentiviral vectors for ex vivo or in vivo therapeutic applications, using expertise in molecular biology, CRISPR, PCR, qPCR, ddPCR, molecular cloning, western blotting, and mammalian cell culture. Production & Optimization: Producing lentivirus, optimising protocols and improving processes to provide high quality and consistent vector yields. Analytical Testing: Performing assays to assess viral titer, potency, transduction efficiency and purity, and developing standardized protocols for vector performance. Core LLV and Analytical Team Leadership: Providing expertise to support technical research staff, troubleshooting, updating protocols, and ensuring regulatory compliance. Implement rigorous experimental design, statistical analysis, and documentation to ensure reproducibility, traceability, and data integrity. Lead data integrity checks related to the Core technical teams activities, ensuring ELN records are completed with ALCOA+ principals. Contribute towards the authoring of nonclinical Reports submitted by the Translational Research team. Develop and implement lab workflows, SOPs and review Risk Assessments and best practices to support the Core LVV & Analytical teams scientific productivity, and drive continuous improvement activities, to oversee the achievement and maintenance of high-quality robust standards of research. Participation in Translational Research departmental meetings to share updates related to the Core Technical teams activities and provide updates on emerging and innovative technologies & platforms in C> Vector and Analytical methods. Provide compliance monitoring related to internal policies, guidelines and regulations governing laboratory activities to the Translational Research team. Act as a primary liaison for the Translational Research Team and Facilities Management Team to foster collaborative relationships between researchers and departments. Work closely with Benchling ELN Administrators to support continuous development of the ELN platform for Orchard's R&D activities including oversight of inventory management, data capture and data integrity. Any other duties allocated which fall within the general area of the position. Education / Key Competencies Experienced molecular/ cellular biologist with strong technical background and analytical abilities to support core technical research staff Being a team player with a 'can-do' attitude and problem-solving skills is a must, with experience of line management Organization, time and project management, prioritizing and the ability to handle a complex, varied workload Ability to work efficiently, both independently and as part of a team, with excellent communication, collaboration and influencing skills. Good computer skills, experience of working with an ELN such as Benchling is highly desirable Ability to deal diplomatically but firmly with difficult situations. Ability to operate in a fast-paced, multi-disciplinary industrial environment, with a customer service mindset Qualifications/ Experience Bachelor's or Master's degree in Biology, Life sciences, Biochemistry, Bioengineering, or cell and gene therapy related scientific field, with typically 8+ years of experience in laboratory operations, preferably within biotech or pharma research settings. Or PhD (or equivalent) in biological sciences or cell and gene therapy related scientific field with experience in laboratory operations, preferably within biotech or pharma research settings.
Orchard Therapeutics plc.
Location: London/Hybrid Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England. Job Summary The Senior Director, Biostatistics is the head of Orchard's Biostatistics function and a key member of the Medical/Clinical Development team, working to provide transformative gene therapies to patients. This role provides a unique opportunity to contribute strategic statistical thinking to clinical drug development across multiple programs, in a dynamic environment. You will be the primary voice for statistical innovation, ensuring that our gene therapy candidates are evaluated using the most robust and efficient methodologies available. This role requires a blend of deep technical expertise and the presence to interact effectively with both internal stakeholders and global regulatory agencies. The position will report to the VP, Clinical Science and will have management responsibility for a team of statisticians and programmers. Key Responsibilities Team building: Build and lead a high-performing Biostatistics team, promote collaboration and advance professional development. Develop and monitor departmental objectives. Ensure adherence to annual budget targets, including effective oversight of third-party vendors. Strategic leadership: Provide input into clinical development plans to ensure statistical integrity, compliance with regulatory requirements, and alignment with Orchard's objectives. Cross-functional and external collaboration: Partner with clinical, regulatory, and medical affairs colleagues, and with external partners and vendors, to support the clinical development of Orchard's assets. Innovation: Explore and implement novel statistical methodologies where possible, considering specific requirements for gene therapy (one time administration and long term follow up) and rare disease/small populations. Regulatory engagement: Represent Orchard as the lead statistician during interactions with global regulatory and health technology agencies. Review/contribute to regulatory briefing documents, defend the statistical integrity of regulatory submissions, and respond to technical questions from agencies. Study design and execution: Provide statistical input as required, including sample size justification, specification of estimands, oversight of SAP/shell production, oversight of vendors, and ensuring correct interpretation of results in study reports and submission documents. Education / Key Competencies 15+ years' experience working as a statistician in drug development including significant interactions with regulatory authorities with at least 5 years in a management role. MSc or PhD in statistics or related discipline. Evidence of strategic input both at the departmental and program level. Excellent communication skills and in particular the ability to communicate complex statistical concepts to non statisticians. Expertise in a range of statistical methodologies with practical applications (experience with rare diseases, small populations or Bayesian methodology would be an advantage). Prior experience of regulatory interactions, including acting as a lead statistician in regulatory submission(s). Prior experience as project statistician including both design and setup of a program and analysis and reporting. Proficiency with SAS (experience with R is an advantage); good knowledge of CDISC standards. Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications. We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment. Notice to All Applicants: Orchard Therapeutics participates in E Verify
Location: London/Hybrid Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England. Job Summary The Senior Director, Biostatistics is the head of Orchard's Biostatistics function and a key member of the Medical/Clinical Development team, working to provide transformative gene therapies to patients. This role provides a unique opportunity to contribute strategic statistical thinking to clinical drug development across multiple programs, in a dynamic environment. You will be the primary voice for statistical innovation, ensuring that our gene therapy candidates are evaluated using the most robust and efficient methodologies available. This role requires a blend of deep technical expertise and the presence to interact effectively with both internal stakeholders and global regulatory agencies. The position will report to the VP, Clinical Science and will have management responsibility for a team of statisticians and programmers. Key Responsibilities Team building: Build and lead a high-performing Biostatistics team, promote collaboration and advance professional development. Develop and monitor departmental objectives. Ensure adherence to annual budget targets, including effective oversight of third-party vendors. Strategic leadership: Provide input into clinical development plans to ensure statistical integrity, compliance with regulatory requirements, and alignment with Orchard's objectives. Cross-functional and external collaboration: Partner with clinical, regulatory, and medical affairs colleagues, and with external partners and vendors, to support the clinical development of Orchard's assets. Innovation: Explore and implement novel statistical methodologies where possible, considering specific requirements for gene therapy (one time administration and long term follow up) and rare disease/small populations. Regulatory engagement: Represent Orchard as the lead statistician during interactions with global regulatory and health technology agencies. Review/contribute to regulatory briefing documents, defend the statistical integrity of regulatory submissions, and respond to technical questions from agencies. Study design and execution: Provide statistical input as required, including sample size justification, specification of estimands, oversight of SAP/shell production, oversight of vendors, and ensuring correct interpretation of results in study reports and submission documents. Education / Key Competencies 15+ years' experience working as a statistician in drug development including significant interactions with regulatory authorities with at least 5 years in a management role. MSc or PhD in statistics or related discipline. Evidence of strategic input both at the departmental and program level. Excellent communication skills and in particular the ability to communicate complex statistical concepts to non statisticians. Expertise in a range of statistical methodologies with practical applications (experience with rare diseases, small populations or Bayesian methodology would be an advantage). Prior experience of regulatory interactions, including acting as a lead statistician in regulatory submission(s). Prior experience as project statistician including both design and setup of a program and analysis and reporting. Proficiency with SAS (experience with R is an advantage); good knowledge of CDISC standards. Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications. We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment. Notice to All Applicants: Orchard Therapeutics participates in E Verify