Director, CMC Product Development – Biologics

About the role

The Director, CMC Product Development – Biologics will lead end‑to‑end CMC activities for biologic drug product candidates, from early formulation through clinical supply and regulatory filing. Reporting to the Executive Director, CMC Product Development, this senior leader shapes the product development strategy for large‑molecule programs such as monoclonal antibodies and fusion proteins.

Key responsibilities

• Define and execute the biologics drug product development strategy, including formulation, fill‑finish, container‑closure, and device development.
• Lead formulation development activities: excipient screening, optimization, forced degradation, and compatibility studies.
• Oversee process development and scale‑up, manage technology transfer to CDMO partners, and ensure validation readiness.
• Author and review biologics sections of IND, BLA, and meeting packages; lead FDA/EMA interactions on CMC topics.
• Select, qualify, and govern CDMO partners for clinical supply, change control, and deviation management.
• Collaborate with Analytical Development and Drug Substance teams to align timelines and deliverables.

Required profile

• Senior technical leader with extensive experience in biologics drug product development.
• Proven track record managing monoclonal antibodies, fusion proteins, or similar modalities.
• Strong cross‑functional collaboration skills with Analytical Development, Quality, Clinical Operations, and external partners.
• Experience preparing regulatory submissions and interacting with FDA/EMA on CMC matters.

Required skills

• Formulation development for protein therapeutics
• Excipient screening and forced degradation studies
• Compatibility and stability testing
• Fill‑finish process development and technology transfer
• Process characterization and validation readiness
• Regulatory submission writing (IND, BLA)
• CDMO selection, qualification, and management
• Primary container‑closure selection and device development