Principal Research Scientist I, Analytical Lead (R&D)

Role: Analytical Lead within AbbVie's Biologics Analytical Research & Development, responsible for developing and executing analytical strategies for biologic programs including antibodies, ADCs, and novel modalities, supporting clinical development and regulatory submissions. Responsibilities: conceive and own analytical development plans covering method validation, characterization, stability, comparability, and control strategies; coordinate with internal labs and external CROs; interpret data across release, stability, and characterization assays; author and review regulatory documents; communicate project status and risks; manage resources and budgets. Requirements: PhD in Chemistry, Biochemistry, or related field with 6+ years (PhD), 12+ years (MS), or 14+ years (BS) of industry experience; comprehensive knowledge of analytical techniques (HPLC, MS, ELISA, etc.) for protein therapeutics; proven project management in biologics analytical development; experience with regulatory submissions (IND/IMPD); GxP environment familiarity; strong communication and collaboration skills. Preferred: regulatory knowledge (FDA, EMA), statistical tools (JMP), and experience with biologics including multi-specifics, ADCs, and novel modalities. HighValue: biologics CMC, analytical development, biologic therapeutics, IND/IMPD, GxP, on-site in South San Francisco, with daily collaboration across global teams.