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: 092217
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: 092217.
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