MSAT Director

Barrington James; Birmingham; Hybrid; GBP 75,000 - 90,000; Full time

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

Biologics MSAT

Technical problem-solving

Excellent communication

Job description

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.