Biologics Downstream Process Development Director

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

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.