Production Scientist I
On-siteSawston, England, United Kingdom
Job Summary
Conduct GMP manufacturing of patient-specific cellular therapy products within Grade A-D cleanrooms, operating biological safety cabinets and isolators while maintaining aseptic techniques. Perform environmental monitoring, disinfect items, and qualify gowning and transfer processes. Act as an operator, support, or verifier using equipment such as ROTEA, CRF, and liquid nitrogen dewars to process and freeze cells. Adhere to MHRA regulations and the Quality Management System by documenting non-conformances, change controls, and risk assessments via eBMR and Labware platforms. Supervise staff on validated SOPs and protocols. This site-based role at the Sawston facility initially follows standard business hours with flexibility for shift patterns as operational needs evolve.
Required Qualifications
- Bachelor's degree (or equivalent) in a science or related discipline
- Experience of cell culture techniques
- Experience in aseptic techniques
- Experience following validated SOPs and protocols
- Working knowledge of GMP for ATMPs and EU regulations for cell and gene therapy
- Ability to work in a team environment with excellent communication
- Ability to adapt to changing environments and to problem solve and make important decisions that affect vital products and services
- Candidates must be eligible to work in the UK
Desired Qualifications
- A Master's degree or experience in a cell therapy / pharmaceutical manufacturing environment
- Experience manufacturing in a controlled clean-room environment at Grades A-C
- Experience in writing reports, change controls, and reporting on deviations, non-conformances, and other quality events using a Quality System
- Experience in automation and closed system processing
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