Scientist III; Biologics Drug Product Development

Exelixis, Inc. seeks Scientist III (Biologics Drug Product Development) in Alameda, CA.

• Responsible for the day‑to‑day execution activities directed to support development and manufacturing of biological (antibody drug conjugates, mAbs, bispecifics) drug products (DP).
• Responsible for formulation development, DP manufacturing process development, DP process technical transfer, activities to support preparation and administration of DP and selection and development of primary container closure.
• Outline, design, execute, and manage various activities in house or at CMO/CRO including maintaining documentation and records up to date.
• Design and execute studies in‑house.
• Perform biophysical characterization and analytical assays for biologics development, including DLS, SEC, CE, cIEF, ELISA, LC‑MS, and peptide mapping.
• Design and execute stability, administration, container closure selection and other DP development and manufacturing related studies.
• Perform hands‑on documentation and data review and present data to functional members and leaders.
• Collaborate effectively within CMC (analytical, drug substance), QA and RA and outside contract laboratories with excellent communication to maintain strong relationships.
• Stay current with journal articles and changing regulatory requirements regarding analytical testing.
• Help to identify and draft work instructions/SOP for relevant analytical methods.