Director, Downstream Process Development and Manufacturing Biologics

Role: Director of Downstream Process Development and Manufacturing Biologics, providing strategic leadership for purification process development, scale-up, and tech transfer of biologics including mAbs, ADCs, and microbial products. Responsibilities: oversee end-to-end downstream unit operations such as viral clearance, process validation, and BLA support; develop phase-appropriate purification strategies; manage transfer to CMOs and oversee scale-up to GMP production; ensure viral safety and implement QbD principles; author technical documentation for regulatory filings; mentor technical teams and collaborate cross-functionally with process development, analytical, regulatory, and quality departments. Requirements: PhD with 5+ years or MS with 8+ years of industry experience in biologics downstream development and manufacturing; extensive expertise in chromatography, filtration, viral clearance, process validation, and cGMP compliance; prior experience managing external manufacturing partners. Preferred: background in antibody, ADC, or fusion protein projects. High-Value: biologics (mAbs, ADCs), process validation, viral safety, CMO management, BLA documentation, cGMP, cross-functional collaboration. Work Setup: hybrid role based in Bridgewater, NJ, with approx. 10-20% travel.