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.