Associate Director, Separation Sciences, Biologics Analytical Development

Role: Associate Director of Separation Sciences within Biologics Analytical Development, leading scientific and technical strategies for separation-based assays supporting biologics development and lifecycle management. Responsibilities: oversee method development, qualification, validation, and transfer of HPLC/UPLC and capillary electrophoresis assays; implement AQbD and risk-based approaches for assay robustness; support regulatory filings and lifecycle activities; lead technology development for GMP separation assays; and manage a team of scientists. Requirements: PhD with 7+ years, MS with 13+ years, or BS with 15+ years in analytical development or related fields; extensive experience in biologics, including monoclonal antibodies, bispecifics, or ADCs; expertise in HPLC/UPLC, capillary electrophoresis, GMP environment, and regulatory standards (ICH, FDA, EMA). Preferred skills include experience with advanced data analytics, automation, and digital tools like Empower and JMP; leadership and team development abilities; and familiarity with regulatory submissions. HighValue: biologics (mAbs, bispecifics, ADCs), analytical development, GMP, regulatory filings, AQbD, lifecycle management. WorkSetup: hybrid in Lexington, MA.