Associate Director, Analytical Development & CMC Statistics

Role: Associate Director of Analytical Development and CMC Statistics leading analytical strategy and statistical support for biologic drug substance and drug product programs in oncology. Responsibilities: oversee analytical method development, validation, transfer, lifecycle management, and data interpretation; develop statistical plans for stability, comparability, specifications, and investigations; ensure compliance with regulatory standards and support lifecycle activities including regulatory submissions and inspections. Requirements: advanced degree (PhD or equivalent) in Statistics, Chemistry, Biochemistry, or related; 10+ years in biopharma supporting CMC analytical development; expertise in biologics analytical methods (chromatography, immunoassays, potency assays); strong statistical knowledge and experience with validation, stability modeling, and data analysis; familiarity with ICH, FDA, EMA guidelines, and GMP. HighValue: biologics, analytical method development, stability, comparability, CMC lifecycle, regulatory support, global submissions. WorkSetup: likely hybrid or onsite with periodic travel to support external CROs/CDMOs and regulatory meetings.