Position Overview
Job Title: Senior Quality Control Scientist
Location: London
Salary: £34,189 to £40,792 per annum (inclusive of London Weighting Allowance)
Hours: Full Time
Contract Type: Permanent
Placed On: 5th July 2024
Closes: 10th July 2024
Job Ref:
Role Summary
King’s College London is seeking a dedicated and experienced Senior Quality Control (QC) Scientist to join our Cell and Gene Therapy (CGT) group. The successful candidate will play a critical role in performing in-house quality control testing for cell and gene therapy products, ensuring adherence to GLP, GMP, and ICH guidelines. This role encompasses the development, validation, and establishment of cutting-edge QC assays, collaboration with external partners, and the supervision of QC team members.
Key Responsibilities
- Quality Control Testing: Conduct QC tests on final products, drug substances, and in-process samples using methods such as flow cytometry, cell proliferation assays, protein assays, western blots, and QPCR.
- Documentation and Compliance: Maintain accurate documentation of test results in compliance with the Pharmaceutical Quality System (PQS), ensuring data integrity. Review testing performed by other QC scientists.
- Assay Development and Validation: Design and validate QC assays in accordance with ICH Q2, GLP, and GMP guidelines. Lead the development of new assays and facilitate the tech transfer of collaborator/client assays into the CGT group.
- Raw Material and Stability Testing: Oversee testing of incoming raw materials and critical manufacturing materials, establishing reference standards where necessary. Maintain stability programs in collaboration with the Head of Quality.
- Audit Participation and Reporting: Engage in internal and external audits, initiate Out-of-Specification (OOS) and deviation reports/investigations, and support batch release timelines. Establish a system for trending QC test results and report findings quarterly.
Candidate Profile
Essential Criteria
- Proven experience in performing QC testing and stability assessments of final products, drug substances, and in-process samples in accordance with predefined specifications and GMP/GLP guidelines.
- Proficiency in using various testing methods, including flow cytometry, cell proliferation assays, protein assays, western blots, and molecular techniques like QPCR.
- Strong documentation skills, adhering to PQS and data integrity principles. Ability to review and ensure the accuracy of testing conducted by team members.
- Expertise in designing and validating QC assays, leading the development of new assays, and managing tech transfers.
- Experience in raw material testing and establishing stability programs, with the ability to supervise and support QC team members.
Desirable Criteria
- Ability to draft clear and comprehensive experimental protocols.
- Hands-on experience with microbiological environmental monitoring.
- Engagement with external meetings related to GLP compliance and QC assay development for ATMPs.
- Ability to establish and report on QC testing trends to senior management.
- Flexibility to perform additional QC-related tasks as required.
Application Process
To apply for this role, please submit your application by 10th July 2024 . We look forward to receiving your application and potentially welcoming you to our team at King’s College London.
For more information, please refer to Job Ref: .
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Full Time Senior Quality Control Scientist Required at King’s College London employer: King's College London
At King’s College London, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our commitment to employee growth is evident through comprehensive training opportunities and a supportive environment that encourages professional development. Located in the heart of London, our institution offers unique advantages such as access to world-class resources and a vibrant community dedicated to advancing research and education.
