Senior Scientist, Purification Process Development

Role

Lead purification process characterization and validation for large molecule development, supporting IND/BLA submission.

Responsibilities

• design and execute chromatography, filtration, and analytical studies
• author protocols, review data, generate reports, and prepare IND/BLA sections
• coordinate with internal teams and CDMOs for late-stage process data and transfer to manufacturing

Qualifications

• PhD in Biology, Biochemistry, Chemical Engineering, or related field
• 5+ years in biotech/biopharma process development
• expertise in purification, process characterization, validation, and analytical methods (HPLC, ELISA, SDS-PAGE, DLS, LC/MS)
• familiarity with BLA authoring and working with CMOs
• experience with viral clearance studies and AKTA systems is preferred

High-Value

• biologics
• large molecule pipeline
• process validation
• late-stage development
• IND/BLA support

WorkSetup

details not specified.