CMC, Process Validation

Working with a biotech company is seeking an experienced leader to oversee late-phase clinical manufacturing of biologic's at external partners. This role involves managing internal project teams and acting as the primary liaison with CDMOs, ensuring successful tech transfer, process validation, and regulatory readiness for live bacterial vaccine products.

Key Responsibilities:

• Lead external manufacturing projects, including on-site oversight during critical activities.
• Manage and mentor a team of project managers.
• Oversee tech transfer, process validation (PPQ), and clinical batch production.
• Ensure GMP compliance and support regulatory submissions (Module 3 of CTD).
• Collaborate with QA and regulatory teams to prepare for inspections and filings.
• Drive internal CMC initiatives and continuous process improvements.

Requirements:

• PhD or Master's in life sciences, biotech, or engineering.
• 15+ years in biologics manufacturing, preferably in sponsor-side roles.
• Strong expertise in PPQ, BLA submissions, and regulatory standards (FDA/EMA).
• Experience with fermentation, aseptic filling, lyophilization; live bacterial products preferred.
• Excellent leadership, communication, and project management skills.
• Fluent in English