Director, Downstream Process Development and Manufacturing Biologics

Scorpion Therapeutics; Bridgewater (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Scorpion Therapeutics seeks a Director of Downstream Process Development and Manufacturing Biologics to lead end-to-end downstream development across unit operations, including viral clearance and QbD, for clinical and commercial manufacturing.

You will develop phase-appropriate downstream purification strategies, direct CMOs, and oversee scale-up to GMP production while ensuring compliant, robust processes. Collaboration across functions is essential to align strategies with business goals.

Qualifications

• PhD with at least 5 years industry experience or MS with at least 8 years in biotech.
• Experience in downstream process development and manufacturing of biologics (antibodies, ADC, fusion proteins).
• Deep experience with chromatography systems, filtration, viral inactivation/removal and CDMO management.

Responsibilities

• 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 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, chromatography-based clearance).
• Supervise development of filtration 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.

Skills

Downstream PD

Chromatography

Filtration

Viral clearance

CDMO management

Process validation

QbD

cGMP regulatory

Cross-functional collaboration

Education

PhD or MS in relevant field

Tools

Chromatography systems

Filtration equipment

Viral inactivation units

Job description

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.