Job Description

The GMP manufacturing facility handles a wide range of cell and gene therapies. The Senior AS Scientist manages and maintains the GMP QC analytical function, ensuring laboratory and QC testing meets MIA (IMP) licence requirements, while supporting the AS function.

Main Areas of Responsibility

• Supervise GMP AS Scientists
• Carry out GMP analytical testing for raw materials, in-process, final product, and stability samples
• Manage qualification/validation of assays for MHRA Licensing
• Support Head of Quality in QC validations
• Develop fit-for-purpose assays with wider Analytical Services Team
• Control systems for test and reference sample management
• Write and approve QC sampling plans and specifications
• Lead GMP technical transfer processes
• Manage QC materials, supply, and outsourced activities
• Perform laboratory investigations and OOS investigations to GMP standards
• Support site Pharmaceutical Quality System including CAPAs
• Support internal and external audits
• Review risk assessments and validation documentation
• Conduct Product Quality Reviews
• Manage and report on environmental monitoring trends

Person Specification

Essential Qualifications & Experience

• Minimum BSc in relevant subject or equivalent experience
• 3+ years GMP Quality and QC operations experience
• Experience leading a small team in a supervisory role
• Understanding of GMP for small scale biopharmaceutical production
• Technical expertise in ATMP analytics: HPLC, FACS, PCR
• Experience with PQS systems (deviations, change management, risk management, OOS, audits, product complaints)
• Experience with C> analytics for assay, purity, identity, safety, potency

Desirable Qualifications & Experience

• In-depth understanding of Pharmaceutical Quality System and QC function
• Understanding of technologies for cell and gene therapy analysis (FACS, HPLC, PCR)
• Knowledge of GLP and routine QC assays (HPLC, PCR, sterility, mycoplasma, ELISA, SDS PAGE)
• Qualified Person with ATMP certification experience

Competences Required

• Organisation, planning, time management
• Commercial awareness, procurement & budget management
• Oral and written communication
• Leadership and teamworking
• Innovation, inquisitiveness, willingness to learn
• Attention to detail
• Problem solving
• Building constructive relationships
• Motivated by growing a CGT / biopharmaceutical business
• Proficiency in Office365 (Word, Excel, PowerPoint)

Salary: £39,000 - £49,000 | Location: [Employer hidden — sign up to reveal], Bristol, UK | Closing Date: 25/05/2026