Dir./Sr. Director, Downstream Biologics Manufacturing

Role: Senior/Director level leadership for downstream biologics manufacturing, supporting late-stage clinical development and commercial readiness of biologic drugs, primarily monoclonal antibodies targeting inflammatory pathways. Responsibilities: lead technical strategy and execution of downstream process development, validation, and tech transfer; oversee external CDMO partnerships, including qualification, process oversight, and performance management; ensure manufacturing compliance with cGMP, ICH, FDA, EMA standards; manage process characterization, validation, impurity clearance, viral safety, and continuous improvement initiatives; support regulatory submissions and inspections; collaborate closely with cross-functional teams including Quality, Regulatory, Supply Chain, and Process Development. Requirements: Ph.D., M.S., or B.S. in Chemical Engineering, Biotech, or related; 10+ years in biologics process development/manufacturing with proven experience in late-stage biologics, including Phase 3 and process validation; strong expertise with downstream purification, viral clearance, and commercial-scale operations; demonstrated CDMO management and regulatory knowledge. High-Value: biologics (monoclonal antibodies), inflammatory disease focus, late-stage/Phase 3, process validation, process transfer, regulatory submission support. Work setup: based in Chesterbrook, PA, with hybrid work model (minimum 2 days in-office); travel up to 30% domestically and internationally.