About The Role
Director, Downstream Process Development and Manufacturing Biologics (Technical Operations CMC) reporting to the Executive Director, Pharmaceutical Development.
What You'll Do
- 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.
Who You Are (Qualifications)
- 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.
Nice to Have
- Degree in Chemical Engineering, Biotechnology, or relevant scientific field.
Director, Downstream Process Development and Manufacturing Biologics in bridgewater at Unknown Company
This position is listed as contract and onsite.