Scientist III (Biologics Drug Product Development) [REF 51684]

Exelixis, Inc. seeks Scientist III (Biologics Drug Product Development) in Alameda, CA. Duties 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. #J-18808-Ljbffr Wilder Wealthy & Wise