QC Validation Specialist

Location: London Type: Permanent Full-Time Sector: Gene & Cell Therapy Manufacturing Confidential Search handled by Joynes & Hunt

Our client is a fast-growing biopharmaceutical manufacturer specialising in advanced gene and cell therapies based in London. As the business continues to scale theyre looking for a QC Validation Specialist to join their Quality Control team and play a key role in bringing life-changing therapies to patients safely and compliantly.

This is a confidential search the identity of our client will be shared with shortlisted candidates ahead of interview.

Youll take ownership of validating and transferring analytical testing methods used to assess gene therapy products and related materials making sure everything aligns with regulatory expectations across both the EU and US markets.

Day to day youll:

• Lead the validation and technology transfer of new and existing analytical test methods for gene therapy products
• Produce robust validation protocols data analyses and reports that stand up to regulatory scrutiny
• Coordinate the transfer of validated methods into GMP-compliant QC laboratories
• Write and maintain clear compliant SOPs for every method you validate
• Keep key stakeholders informed on progress against method transfer plans and timelines
• Periodically review analytical methods already in use confirming they continue to perform as expected
• Contribute to the wider Quality Management System with a strong focus on data integrity
• Take ownership of your own training KPIs and objectives ensuring GMP compliance throughout
• Close out quality documentation including CAPAs change controls and audit actions accurately and on time
• Occasionally support hands-on testing of gene therapy products to keep production schedules on track

• A degree or Masters in a life sciences or health-related discipline
• At least 2 years experience in a regulated environment such as pharmaceuticals or biologics
• A proven background in analytical method validation ideally within a research or pharmaceutical setting
• Familiarity with techniques such as qPCR HPLC ELISA Western blotting cell culture and DNA extraction
• Working knowledge of ICH Q2(R1) guidance
• A strong communicator comfortable presenting data and updates to varied audiences
• A methodical detail-driven approach with a genuine passion for quality

For a confidential conversation about this role get in touch with Joynes & Hunt.