Senior Director, Analytical Development

Role: Senior Director of Analytical Development leading strategic and operational aspects of biologics analytical functions. Responsibilities: define long-term analytical strategies supporting biologics from candidate selection through commercialization, oversee method lifecycle management, establish control strategies, manage external testing partnerships, and ensure regulatory compliance; lead a high-performing, cross-functional analytical team; provide technical oversight during manufacturing, investigations, and regulatory submissions; and advance analytical technologies. Requirements: Ph.D. in Biochemistry, Analytical Chemistry, or related field with 15+ years’ experience in biologics analytical development; expertise in monoclonal antibodies and complex protein therapeutics; extensive knowledge of analytical method development, qualification, validation, and lifecycle management; proven leadership in biotech/pharma, particularly managing external partners and building teams; familiarity with GMP, data integrity, and regulatory processes. HighValue: biologics (mAbs, recombinant proteins), late-stage development, GMP/QA oversight, analytical lifecycle management, IND/BLA support, cross-functional leadership, external collaboration. WorkSetup: fully virtual with extensive external partner engagement.