Principal Scientist/Director (Downstream), Biologics Drug Substance Commercialization (BDSC)
Core
Lead downstream purification teams for late-stage and commercial biologics drug substances, ensuring process readiness for global manufacturing and licensure.
Role type
Senior IC/People Leader (Principal Scientist/Director)
Builds
Late-stage and commercial biologics drug substances
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Downstream processing, Biologics purification, Process development, Technology transfer, Scale-up, Process validation, GMP manufacturing, Regulatory documentation, Team leadership, Strategic planning
Preferred skills
Multi-specific antibody therapeutics, Preparative chromatography, Tangential flow filtration, Viral clearance studies, PPQ, Lean leadership
Technologies
Preparative chromatography, Tangential flow filtration, Virus retentive filtration
Responsibilities
Lead downstream teams for late-stage and commercial programs; Provide technical leadership for lab and manufacturing scale studies; Support technology transfer and scale-up; Author regulatory submission content; Mentor and develop scientific staff; Drive division-wide manufacturing initiatives.
Seniority
Principal, hands-on IC with people leadership