Principal Scientist, Analytical Development (Biologics)
Core
Lead analytical development for biologics (monoclonal antibodies, conjugates) from preclinical through commercial phases, ensuring cGMP compliance and supporting CMC strategies.
Role type
Principal Scientist, Analytical Development (Biologics)
Builds
Drug substance and drug product controls for biopharmaceutical treatments
Domain
Biopharmaceuticals / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biologics analytical method development and validation, cGMP compliance, CQA assessment, stability study design, cross-functional project management, regulatory documentation (IND/IMPD), separation science (UPLC, CE-SDS, iCIEF), bioassay development, mass spectrometry, ELISA, method transfer
Preferred skills
Postdoctoral experience, extensive vendor management, strategic policy development
Technologies
SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF, ELISA, cell-based bioassay, qPCR, LC, UPLC/HPLC, capillary electrophoresis, gel electrophoresis, mass spectrometry
Responsibilities
Lead analytical method development and validation for biologics; Represent analytical development on cross-functional teams; Direct laboratory work and external vendors; Provide input into CMC regulatory documentation; Contribute to department strategies; Support team member technical growth; Present findings across the company
Seniority
Principal, hands-on IC with strategic influence
