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.
What You’ll Do
* 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
What You Bring
* 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.