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