Senior Director Manufacturing (Biologics)
Position Overview
A biologics manufacturing organization is seeking a Senior Director of Manufacturing to lead large-scale mammalian cell culture operations (mAbs) across clinical and commercial programs.
This is a highly visible leadership role responsible for end-to-end cGMP manufacturing, regulatory readiness, and operational performance at a rapidly expanding site. The role requires a hands-on, execution-focused leader who can operate at both the strategic and operational level, partnering closely with senior leadership and cross-functional teams.
Key Responsibilities
- Lead and oversee cGMP manufacturing operations for biologic drug substance (mAbs) across clinical and commercial stages
- Manage and develop a large-scale manufacturing organization (~200+ FTEs)
- Drive site performance, scalability, and operational excellence during a period of expansion
- Partner closely with Quality and senior leadership to ensure inspection readiness and compliance
- Play a key role in regulatory inspections (FDA and others), including direct involvement during audits
- Support manufacturing contributions to IND/BLA filings (preferred)
- Act as a primary point of contact for clients during site visits and manufacturing discussions
- Implement and drive continuous improvement and LEAN manufacturing systems
- Lead organizational growth, including team scaling, structure, and talent development
Required Qualifications
- Extensive experience in biologic drug substance manufacturing (protein experience strongly preferred)
- Background in mammalian cell culture manufacturing
- Proven leadership of large, complex manufacturing teams
- Strong experience in clinical and commercial manufacturing environments
- Demonstrated involvement in regulatory inspections and compliance readiness
- Experience in CDMO or similarly fast-paced manufacturing environments strongly preferred
- Track record of driving operational improvements, scalability, and performance outcomes
Leadership Profile
- Recognized leader with the ability to operate in a high-growth, execution-driven environment
- Demonstrated ability to scale teams and organizations effectively during expansion
- Comfortable working closely with executive leadership and external clients
- Strong balance of strategic oversight and hands-on operational involvement
Additional Information
- Onsite role, 5 days/week
- Standard travel expectations, including client-facing responsibilities
- Full relocation support available
- Role is part of an expanded leadership structure at a growing manufacturing site
Target Candidate Profile
- Experience in biologics manufacturing at scale (CDMO experience highly preferred)
- Background leading organizations through growth, scale-up, and regulatory milestones
- Demonstrated success in building high-performing teams in complex environments
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