Associate Director, Drug Substance Manufacturing – Downstream Process

Role: Associate Director of Drug Substance Manufacturing – Downstream Process at Vera Therapeutics, focusing on biologics, particularly monoclonal antibodies. Objectives include overseeing downstream manufacturing activities, technology transfer, lifecycle management, and regulatory support for complex biologics. Responsibilities: lead technical oversight of global CMO operations, manage process scale-up, validation, deviations, and continuous improvement; author and review CMC regulatory submissions (e.g., BLA, MAA); support post-approval lifecycle strategies and process monitoring. Qualifications: MS in life sciences or engineering with 5+ years (or BS with 8+ years) experience in biologics downstream processes, GMP manufacturing, and technology transfer; hands-on expertise in chromatography, UF/DF, viral clearance; experience managing CMOs and cross-functional teams; strong project management, problem-solving, and communication skills. HighValue: biologics, monoclonal antibodies, downstream processing, process validation, CMC regulatory submissions, global manufacturing, lifecycle management, GMP compliance. WorkSetup: not specified.