Principal Scientist, Purification Process Development

Role: Lead purification process characterization and validation for biopharmaceutical large molecule pipeline, supporting IND/BLA submissions. Responsibilities: independently manage downstream process development, tech transfer, and late-stage activities; author protocols and regulatory sections; coordinate data generation with internal teams and CDMOs; transfer processes to manufacturing; support cell line and culture workflows; execute analytical testing (ELISA, HPLC, SDS-PAGE). Requirements: PhD in Biology, Biochemistry, Chemical Engineering, or related field; 10+ years in bioprocess development with expertise in purification, process validation, and analytics; experience with AKTA systems, antibody characterization techniques, and batch review; familiarity with BLA authoring and viral clearance studies preferred. HighValue: biologics, large molecules, process validation, IND/BLA preparation, late-stage process development, CDMO collaboration, biophysical analytics. WorkSetup: not specified; salary range: $159K-$207K; comprehensive benefits.