Dir./Sr. Director, Upstream Biologics Manufacturing

Role: Senior leadership in upstream biologics manufacturing, focusing on process development, technology transfer, and commercial readiness for biologic drug substance production. Responsibilities: oversee external CDMO manufacturing, ensure process robustness, lead process validation, troubleshoot manufacturing issues, and maintain regulatory compliance; collaborate cross-functionally with Quality, Regulatory, Supply Chain, and Program Management; manage vendor relations and participate in contract negotiations. Requirements: Ph.D., M.S., or B.S. in Chemical Engineering, Biotechnology, or related fields; 10+ years in biologics process development or GMP manufacturing; extensive experience with mammalian cell culture, process validation, and technology transfer; familiarity with regulatory frameworks (ICH, FDA, EMA). High-Value: biologics (monoclonal antibodies, recombinant proteins), late-stage clinical development (Phase 3), process validation/PPQ, cGMP compliance, global CDMO oversight, up to 30% travel, hybrid work model based in Chesterbrook, PA.