Senior Director of Manufacturing – Biologics

About the role

A leading biologics manufacturing organization is seeking a Senior Director of Manufacturing to oversee large‑scale mammalian cell‑culture (mAb) operations across clinical and commercial programs. This high‑visibility position combines strategic leadership with hands‑on execution to drive site performance, scalability, and regulatory readiness.

Key responsibilities

• Lead cGMP manufacturing of biologic drug substance (mAbs) for clinical and commercial stages.
• Manage a large‑scale manufacturing organization of 200+ FTEs, ensuring operational excellence during rapid expansion.
• Partner with Quality and senior leadership to maintain inspection readiness and compliance.
• Participate directly in FDA and other regulatory inspections and audits.
• Support manufacturing contributions to IND/BLA filings.
• Serve as primary client contact during site visits and manufacturing discussions.
• Implement continuous‑improvement and LEAN manufacturing systems.
• Drive organizational growth, team scaling, structure, and talent development.

Required profile

• Extensive experience in biologics drug‑substance manufacturing, preferably protein‑based.
• Deep background in mammalian cell‑culture manufacturing.
• Proven leadership of large, complex manufacturing teams (100+ staff).
• Strong experience in both clinical and commercial manufacturing environments.
• Hands‑on involvement in regulatory inspections and compliance readiness.
• Experience in CDMO or fast‑paced manufacturing settings is strongly preferred.

Required skills

• Mammalian cell‑culture manufacturing
• cGMP manufacturing processes
• LEAN manufacturing methodologies
• Regulatory inspection readiness (FDA, etc.)
• IND/BLA filing support

What we offer

• On‑site role with a five‑day work week.
• Standard travel expectations, including client‑facing responsibilities.
• Full relocation support.
• Opportunity to shape a growing manufacturing site within an expanded leadership structure.