Principal Scientist, Analytical Development

About The Role: This position will serve as analytical development lead for multiple projects focused on monoclonal antibodies, including complex modalities such as bi-specific, tri-specific, and fusion proteins. Guide analytical activities for drug substance and drug product development from preclinical through commercial phase. Develop, establish, validate/qualify analytical methods to control in-process intermediates, drug substance, and drug products. Contribute to development and implementation of control strategies and ensure work complies with cGMP, safety, and regulatory requirements. Participate in analysis/evaluation of materials and products throughout development and monitor task/project completion. Your Contributions (include, but are not limited to): Lead analytical method development and validation/qualification for monoclonal antibodies in cGMP compliance from preclinical through commercialization Represent Analytical Development on cross-functional teams; maintain accountability for analytical deliverables and CMC/manufacturing plan progress Direct laboratory work and/or lab personnel (company and external vendors) Provide expertise in separation techniques (e.g., SEC/RP/HILIC/IEX/HIC/Mixed Mode/2D-LC, CE-SDS, iCIEF) Support off-site analytical method transfers and manufacturing support; interact with external vendors Provide input into CMC regulatory documentation; leverage literature/ICH guidance to influence CMC strategies Contribute to policies/department strategies; build relationships; support team growth; present findings; other duties as assigned Requirements: BS/BA in Analytical Chemistry (or related) + 12+ years analytical/pharmaceutical development, including method transfer experience OR MS/MA + 10+ years OR PhD + 4+ years (may include postdoc) Expert knowledge of analytical chemistry, separation sciences, bioprocess, and formulation development Extensive experience with monoclonal antibody analytical method development (release/stability) Strong interpersonal, oral/written communication, laboratory, and productivity skills Proficiency characterizing monoclonal antibodies (e.g., SEC/HPLC/UPLC, CE-SDS/iCIEF, electrophoresis, MS, ELISA, bioassays) Method development, validation, qualification, and transfer experience Comprehensive cGMP knowledge (drug substance and drug product) Cross-functional drug development understanding Knowledge of FDA/EMA/WHO/ICH regulatory requirements #J-18808-Ljbffr