Overview
In this role you will lead QC activities for a gene-edited cell therapy program, coordinating with external labs to ensure compliant GMP release and stability testing. You will support commercial QC operations, drive lifecycle improvements for analytical methods, and oversee regulatory compliance in a hybrid London-based setting. You will partner with cross-functional teams to manage risks, investigations, and data integrity, enabling timely product release. This is a hands-on, impact-driven position at the intersection of quality, science, and regulatory compliance.
Pay / Benefits
- Hybrid-Eligible
- On-Site eligibility
- ad hoc flexibility
Responsibilities
- Lead QC activities at contract laboratories for release and stability testing, validation, and ensuring timelines
- Manage QC operations for a gene-edited cell therapy product and troubleshoot analytical methods related to release
- Oversee commercial reference standards and assay controls programs to ensure compliance and supply continuity
- Troubleshoot analytical methods and equipment as needed
- Author/review/approve data, SOPs, COAs, methods, protocols, and reports
- Ensure external lab records comply with cGMP/GDP expectations
- Lead compliance-focused teams for continuous improvement
- Lead OOS/OOT investigations and assist with corrective actions
Key requirements
- Bachelor's Degree in science or related discipline
- Typically 8 years of pharmaceutical/biopharmaceutical experience
- Experience managing GMP external contract test labs
- Strong knowledge of US/EU cGMP regulations and some regulatory inspections experience
- Experience with batch release, OOS/OOT investigations, reference standards/assay controls, stability studies, LIMS, and raw materials testing
- Laboratory experience with assays related to release of biologics or cell therapies
- Working knowledge of compendial safety testing for GMP drug products
- Effective verbal and written communication
- Attention to detail
- Strong problem-solving and troubleshooting
- cGMP/regulatory knowledge (US/EU)
- QC testing and release of biologics/cell therapies
- OOS/OOT investigations
Technical Quality Control Senior Manager - Casgevy in London employer: Vertex Pharmaceuticals
Vertex Pharmaceuticals is an exceptional employer, offering a dynamic work environment at their Milton Park R&D facility in Abingdon, where innovation thrives. Employees benefit from a strong focus on professional development, with access to training resources that foster growth in the pharmaceutical industry. The inclusive culture encourages collaboration across disciplines, making it a rewarding place for those passionate about making a meaningful impact through science.
