Director Analytical Development

Role: Director of Analytical Development, Analytical Development and Quality Control (ADQC), leading strategic and technical efforts for biologics programs from early development through commercialization. Responsibilities: oversee analytical control strategies, method development, validation, transfer, lifecycle management, and ensure analytical readiness for late-stage and commercial phases; perform hands-on laboratory work; troubleshoot and optimize methods; manage reference standard and critical reagent programs; author regulatory CMC sections; scale capabilities, oversee equipment qualification, and implement workflows. Collaborate with QC, QA, process development, manufacturing, regulatory affairs, and external partners to ensure compliance with cGMP, ICH, USP, and industry standards; ensure inspection readiness; lead external analytical activities and manage external partnerships. Requirements: PhD preferred in Biochemistry, Biophysics, or related field; 8+ years in biopharma, including 4+ years in management within biologics analytical development; expertise in A280, HPLC, CE, LC-MS, ELISA, cell-based potency; strong understanding of analytical strategies, validation, transfer, and regulatory guidelines; proven success supporting regulatory submissions and managing outsourcing. HighValue: biologics, late-stage development, BLA/MAA submissions, cGMP compliance, analytical method lifecycle, hands-on laboratory expertise. WorkSetup: remote; travel not typical.