Sr. Director - Biologics Purification

Role: Senior Director leading the purification and viral safety CMC functions in biologics development, including monoclonal antibodies, bispecifics, recombinant proteins, AAV, and bioconjugates. Responsibilities: oversee downstream process development, scale-up, viral clearance strategies, technology transfer, and regulatory submissions; set strategic direction, drive innovation with emerging technologies like AI/ML, and ensure compliance with evolving regulatory standards. Collaborate with Discovery, Manufacturing, and Regulatory teams to advance programs from preclinical through registration; develop talent and manage laboratory operations with a focus on safety. Requirements: Ph.D. in Chemistry, Biochemistry, Chemical Engineering, or related field with 10+ years of industry experience, or BS/MS with 18+ years applicable experience; proven expertise in downstream bioprocessing, viral safety, and bioproduct development; strong leadership and communication skills. Preferences: experience across end-to-end biologics CMC workflows, GMP technology transfer, regulatory filings, and leveraging AI tools. HighValue: biologics (monoclonals, bispecifics, AAV), downstream process development, viral safety, regulatory submissions, technology transfer, process innovation, global collaboration, <10% travel. WorkSetup: laboratory environment, less than 10% travel.