RoleLead purification process characterization and validation for large molecule development, supporting IND/BLA submission.
Responsibilitiesdesign 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-Valuebiologics
large molecule pipeline
process validation
late-stage development
IND/BLA support
WorkSetupdetails not specified.
