Director, Downstream Process Development and Manufacturing Biologics
Insmed Incorporated
August 06, 2026
Remote friendly (Bridgewater, NJ)
United States
Operations
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 (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.