Assoc. Director, Analytical Development

Role: Associate Director of Analytical Development overseeing biologics portfolio, providing scientific and operational leadership for analytical methods supporting drug development from preclinical to late-stage and commercialization. Responsibilities: lead method development, qualification, transfer, and testing activities at external CDMOs and CTLs; develop strategies for potency, impurities, and release assays; interpret quality data to define CQAs and control strategies; author and review regulatory documentation; manage external partnerships; ensure compliance with evolving regulatory standards; mentor internal teams and collaborate with QC and Quality functions. Requirements: PhD in Chemistry, Biochemistry, or related field with 8–12 years (or BS/MS with 10–12 years) relevant biologics analytical experience supporting preclinical through late-stage programs; deep expertise in biologics assays, GMP validation, and lifecycle management; proven regulatory support and external partner management skills; excellent communication abilities. HighValue: biologics (protein therapeutics), analytical development for potency and impurities, biologics development stages, CMC regulatory contributions, GMP compliance, external partner oversight. WorkSetup: not specified; likely hybrid or on-site, with emphasis on external collaboration.