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MSAT Director
Job summary
A leading biopharmaceutical company in Birmingham is seeking an experienced MSAT Associate Director for a 12-month contract. This full-time role involves overseeing late-stage biologics manufacturing, leading technical process ownership, and ensuring compliance with GMP operations. Candidates should have over 5 years of experience in biologics MSAT or GMP manufacturing, alongside strong problem-solving and communication skills. This position offers a hybrid work model, providing a dynamic environment for professional growth.
Qualifications
- 5+ years in biologics MSAT, PD, or GMP manufacturing.
- Expertise in late-stage or commercial biologics processes.
- Strong understanding of cGMP, ICH, and regulatory expectations.
Responsibilities
- Serve as process owner for late-stage upstream / downstream biologics processes.
- Lead investigations, CAPAs, and manufacturing issue resolution.
- Drive tech transfer to internal / external GMP sites and support PPQ.
- Support process characterization, control strategy, and lifecycle management.
- Provide CMC input for regulatory submissions (BLA / MAA).
- Partner cross-functionally with PD, Quality, Regulatory, Supply Chain, and Manufacturing.
- Mentor the MSAT team and help build a high-performing technical team.
Skills
We are seeking an MSAT Associate Director, for 12 months to support late-stage biologics manufacturing and prepare our lead program for commercialisation. This role provides technical leadership across process robustness, technology transfer, and GMP operations during Phase 3 execution. This is full time for 5 days a week being a hybrid role.
- Serve as process owner for late-stage upstream / downstream biologics processes
- Lead investigations, CAPAs, and manufacturing issue resolution
- Drive tech transfer to internal / external GMP sites and support PPQ
- Support process characterization, control strategy, and lifecycle management
- Provide CMC input for regulatory submissions (BLA / MAA)
- Partner cross-functionally with PD, Quality, Regulatory, Supply Chain, and Manufacturing
- Mentor the MSAT team and help build a high-performing technical team
- 5+ years in biologics MSAT, PD, or GMP manufacturing
- Expertise in late-stage or commercial biologics processes
- Strong understanding of cGMP, ICH, and regulatory expectations
- Experience with tech transfer, validation, or PPQ preferred
- Excellent communication and technical problem-solving skills
If you are an MSAT Consultant and are seeking your next position I would love to connect.
Apply directly or message for a confidential discussion.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.