PpA biologics manufacturing organization is seeking a Senior Director of Manufacturing to lead large-scale mammalian cell culture operations (mAbs) across clinical and commercial programs. /p pThis 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. /p h3Key Responsibilities /h3 ul liLead and oversee cGMP manufacturing operations for biologic drug substance (mAbs) across clinical and commercial stages /li liManage and develop a large‑scale manufacturing organization (~200+ FTEs) /li liDrive site performance, scalability, and operational excellence during a period of expansion /li liPartner closely with Quality and senior leadership to ensure inspection readiness and compliance /li liPlay a key role in regulatory inspections (FDA and others), including direct involvement during audits /li liSupport manufacturing contributions to IND/BLA filings (preferred) /li liAct as a primary point of contact for clients during site visits and manufacturing discussions /li liImplement and drive continuous improvement and LEAN manufacturing systems /li liLead organizational growth, including team scaling, structure, and talent development /li /ul h3Required Qualifications /h3 ul liExtensive experience in biologic drug substance manufacturing (protein experience strongly preferred) /li liBackground in mammalian cell culture manufacturing /li liProven leadership of large, complex manufacturing teams (100+) /li liStrong experience in clinical and commercial manufacturing environments /li liDemonstrated involvement in regulatory inspections and compliance readiness /li liExperience in CDMO or similarly fast‑paced manufacturing environments strongly preferred /li liTrack record of driving operational improvements, scalability, and performance outcomes /li /ul h3Additional Information /h3 ul liOnsite role, 5 days/week /li liStandard travel expectations, including client‑facing responsibilities /li liRole is part of an expanded leadership structure at a growing manufacturing site /li /ul h3Target Candidate Profile /h3 ul liExperience in biologics manufacturing at scale (CDMO experience highly preferred) /li liBackground leading organizations through growth, scale‑up, and regulatory milestones /li liDemonstrated success in building high‑performing teams in complex environments /li /ul /p #J-18808-Ljbffr