At a Glance
- Tasks: Validate and transfer analytical testing methods for gene therapy products.
- Company: Fast-growing biopharmaceutical manufacturer in London.
- Benefits: Competitive salary, career growth, and the chance to impact patient lives.
- Other info: Dynamic role with opportunities for hands-on testing and professional development.
- Why this job: Join a team making life-changing therapies accessible and compliant.
- Qualifications: Degree in life sciences and 2 years' experience in a regulated environment.
The predicted salary is between 36087 - 44107 £ per year.
Location: London | Type: Permanent, Full-Time | Sector: Gene & Cell Therapy Manufacturing
About the Opportunity
Our client is a fast-growing biopharmaceutical manufacturer specialising in advanced gene and cell therapies, based in London. As the business continues to scale, they're 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.
The Role
- You'll 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.
- 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.
What We're Looking For
- A degree or Master's 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.
How to Apply
For a confidential conversation about this role, get in touch with Joynes & Hunt.
QC Validation Specialist in London employer: Joynes & Hunt
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We think you need these skills to ace QC Validation Specialist in London
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Joynes & Hunt that you have the hands-on skills they need.
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