Senior Manager, Analytical Manufacturing Science and Technology

Role: Senior Manager of Analytical Manufacturing Science and Technology (MST) leading analytical method transfers and overseeing the MST Analytical Laboratory supporting biologic drug substance and drug product manufacturing. Responsibilities: provide strategic and technical oversight for analytical capabilities, manage method transfers of physicochemical, potency, and structural characterization to QC labs, support analytical readiness for new product launches and lifecycle projects, perform or supervise testing using HPLC/UHPLC and CE technologies, author and review GMP documentation, support regulatory submissions, establish metrics and governance for transfer progress, and lead cross-functional collaboration with manufacturing, quality, CMC, regulatory, and external partners. Manage and develop laboratory personnel, build a capable analytical team supporting tech transfer and process development. Requirements: Bachelor's in analytical chemistry, biochemistry, or related field with 7+ years biopharma experience; expertise in biologics analytical methods and protein QC attributes; 5+ years of leadership in analytical teams or projects; experience with analytical method transfer, validation, and regulatory documentation. Preferred: Master's degree, experience with regulatory submissions, lab start-up, or capability expansion. High-Value: biologics (monoclonal and bispecific antibodies), analytical method transfer, GMP, biologics QC, lifecycle support, global cross-functional collaboration. Work setup: up to 10% travel.