You will need to have: Advanced degree (PhD or MSc) in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field with 8-12+ years of progressive experience in biologics analytical development across clinical and commercial stages Validated first-hand expert knowledge and technical proficiency with monoclonal antibodies, bispecifics, fusion proteins Technical expertise in chromatography (e.g., SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays (binding, potency), and residuals/impurities testing (HCP, DNA, residual Protein A) Compendia method experience emphasizing USP, EP and JP compliance Strong written and verbal skills for clear reports, regulatory submissions, and presentations to technical and non-technical collaborators Demonstrated success in method development, qualification/validation (per ICH Q2), transfer to QC/CMOs, and continued verification for commercial control strategies Strong command of ICH (Q5E, Q6B, Q8-Q12), USP/EP, FDA/EMA expectations for biologics, GMP/GLP compliance, and authoring/reviewing CTD Module 3, IND/IMPD, BLA/MAA analytical sections and responses to agency queries Proficiency with GxP compliant documentation, ALCOA+ data integrity principles, OOS/OOT handling, deviation/CAPA management, and audit readiness Ability to define critical quality attributes (CQAs), build specifications, and implement control approaches aligned with Quality by Build (QbB). You will be responsible for: Leading all aspects of analytical method validation, transfers, and compendia method verifications across all stages of clinical development and method life-cycle stages Analytical lead for CMC programs, emphasizing late-stage programs, which may be internal or external with cross functional collaboration Analytical end-to-end strategy for key late-stage biologics programs including analytical control strategy, method lifecycle and QC testing supervision, problem resolution and inquiries, and key BLA/commercial analytical Supervision of analytical QC testing, problem-solving, and data analysis are conducted for the CMC program.