Principal Scientist - Process Development, Downstream
Core
Lead downstream process development for biologics manufacturing, focusing on technical transfer, scale-up, and commercial readiness for mAbs and recombinant proteins.
Role type
Principal Scientist, Process Development (Downstream)
Builds
Clinical and commercial manufacturing processes for biologics
Domain
Biopharmaceuticals / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
chromatography, ultrafiltration/diafiltration (UF/DF), viral filtration, cell removal, technology transfer, process characterization, scale-up, cGMP compliance, client-facing scientific leadership
Preferred skills
CDMO environment experience, cross-functional team leadership, viral clearance studies, late-stage process development, commercial manufacturing readiness
Technologies
chromatography, UF/DF, viral filtration, cell removal
Responsibilities
Provide strategic direction for downstream process development programs; guide design and optimization of purification and viral clearance processes; act as primary technical contact for client projects; lead technology transfer and scale-up activities; collaborate with manufacturing and quality teams; author and review technical documentation; mentor scientific staff
Seniority
Principal, hands-on IC with strategic oversight