Senior Director Manufacturing (Biologics)

Senior Director Manufacturing (Biologics) EPM Scientific - 3.3 Madison, WI Job Details $240,000 - $260,000 a year 2 days ago Qualifications Regulatory inspections Manufacturing management Cell line culture Team leadership Manufacturing facility Regulatory readiness in healthcare Bioprocessing Scalability Biomedical regulatory compliance Managing manufacturing teams Operational excellence initiatives Manufacturing Senior leadership Pharmaceutical manufacturing facility experience Full Job Description 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 (100+) 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 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 If this sounds like a good fit for you, please apply in!