Sr Scientist, Purification Process Development (Pivotal & Commercial)

Role: Senior Scientist in Purification Process Development for pivotal and commercial biologics programs, leading process design, characterization, technology transfer, and regulatory documentation. Responsibilities: oversee chromatography, TFF, virus filtration, and clearance; provide scientific leadership across development stages; support tech transfer and manufacturing; perform data analysis; author technical and regulatory reports; collaborate with cross-functional teams; mentor junior staff and support lab infrastructure. Qualifications: Ph.D. with 2+ years, M.S. with 6+ years, or BS with 8+ years in chemical engineering, biochemistry, or bioengineering; experience in GMP, pivotal stage purification, process transfer, and regulatory submissions preferred. HighValue: biologics, Phase II/III and post-launch, process characterization, GMP manufacturing, regulatory documentation (BLA), cross-functional collaboration, data modeling (JMP, Spotfire). WorkSetup: likely onsite with some travel; leadership role with potential team management.