Associate Director, Drug Substance Manufacturing – Upstream Process

Role: Associate Director, Drug Substance Manufacturing – Upstream Process, overseeing biologics upstream manufacturing activities at Vera Therapeutics. Responsibilities: serve as SME for outsourced drug-substance upstream processes, lead tech transfer, validation, process improvements, lifecycle management, and support regulatory submissions (e.g., BLA, MAA). Manage interactions with global CMOs, lead investigations, supervise campaign readiness, and ensure compliance with GMP and global regulatory standards. Qualifications: MS in life sciences or engineering with 5+ years (or BS with 8+ years) in biologics upstream processes, process development, and cGMP manufacturing. Hands-on experience in cell culture, process validation, technology transfer, and managing CDMOs. Preferred: experience in process sciences/MSAT, leadership in cross-functional CMC programs, and excellent organizational skills. High-Value: biologics (monoclonal antibodies, recombinant therapeutics), upstream processing, global regulatory support, lifecycle management, CMC authoring, and manufacturing operations. Work setup: not specified.