Director, Downstream Process Development and Manufacturing Biologics

About The Role

Director, Downstream Process Development and Manufacturing Biologics (Technical Operations CMC) reporting to the Executive Director, Pharmaceutical Development.

• Lead end-to-end downstream process development across unit operations, including viral clearance, process characterization (QbD), process validation, and BLA-enabling activities for clinical/commercial manufacturing.
• Develop and implement phase-appropriate downstream purification strategies for early/late-stage pipeline projects.
• Direct development and transfer of processes to Contract Manufacturing Organizations (CMOs); oversee scale-up to pilot/GMP commercial production.
• Provide technical oversight and direction to CDMO partners to ensure robust, scalable, compliant manufacturing.
• Define and oversee viral safety strategies (viral inactivation, viral filtration (VF), chromatography-based clearance).
• Supervise development of filtration (VF, UFDF) and chromatography steps; implement QbD for characterization and validation.
• Stay current on emerging downstream process technologies.
• Author/review technical documents including BLA filings, CMC sections, and viral clearance studies.
• Coach, mentor, and provide technical guidance.
• Collaborate cross-functionally to align technical strategies with organizational/business objectives.

• PhD with at least 5 years industry experience, or MS with at least 8 years industry experience.
• Downstream process development and manufacturing of biologics (antibodies, ADC, fusion proteins).
• Deep experience with chromatography systems, filtration, viral inactivation/removal, and CDMO management.
• Experience/knowledge in process characterization and process validation.
• Extensive understanding of cGMP regulations and ICH guidelines.
• Ability to work collaboratively using diverse perspectives.

• Degree in Chemical Engineering, Biotechnology, or relevant scientific field.