Manufacturing Programs Senior Manager: New Product Introduction (NPI)

Role: Manufacturing Programs Senior Manager (NPI) overseeing new biologics drug substance introductions at Amgen's advanced NC facility, with a focus on integrating cutting-edge disposable and traditional technologies aligned with Industry 4.0 and sustainability goals. Responsibilities: lead cross-functional teams in technical transfer, troubleshoot manufacturing issues, develop and update production documentation, and champion continuous improvement initiatives including Lean and Operational Excellence. Manage and mentor NPI manufacturing specialists to ensure successful product launches and process robustness. Requirements: Doctorate with 2+ years biotech operations, or Master's with 6+ years experience, or Bachelor's with 8+ years in biologics manufacturing; minimum 2 years leadership experience. Preferred qualifications include a degree in Chemical Engineering, Biology, or Biochemistry, GMP manufacturing expertise, strong project management, technical writing, and knowledge of bioprocessing (cell culture, chromatography, filtration). High-value: biologics, drug substance manufacturing, cell culture/purification, tech transfer, GMP, operational excellence, cross-disciplinary collaboration. Work setup: likely onsite at the new NC plant, with a focus on integration into a state-of-the-art, sustainable manufacturing environment.