Principal Scientist, Analytical Development

Role: Lead analytical development for biologics, including monoclonal antibodies, bispecifics, trispecifics, and antibody conjugates, supporting drug development from preclinical to commercial phases. Responsibilities: develop, validate, and qualify analytical methods for drug substance and product, ensure regulatory compliance (cGMP), support tech transfer, and contribute to CMC strategies; oversee lab operations and external vendors; support regulatory documentation and cross-functional team collaboration. Requirements: BS/BA in Analytical Chemistry or related and 15+ years, MS/MA with 13+ years, or PhD with 7+ years of relevant biopharma experience; expert knowledge in biologics characterization, stability, CQAs, and modern analytical techniques (e.g., UPLC, LC-MS, ELISA, bioassays); extensive regulatory knowledge (FDA, EMA, ICH) and experience with IND filings; strong communication and project management skills. HighValue: biologics, monoclonal antibodies, bispecifics, trispecifics, antibody conjugates; analytical method development and transfer; cGMP compliance; preclinical through commercialization; cross-functional collaboration. WorkSetup: not specified.