Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness

Role: Specialist Manufacturing NPI - Upstream Readiness at Amgen's biologics production facility, focusing on ensuring successful introduction of new drug substances into the manufacturing process. Responsibilities: coordinate cross-functional teams (Manufacturing, Process Development, Supply Chain, Quality, Facilities, Engineering) for tech transfer, lead or support projects ensuring accurate documentation, troubleshoot manufacturing issues, manage Change Controls, and drive continuous improvement initiatives like Lean and Operational Excellence. Requirements: high school diploma plus 10 years, associate's degree plus 8 years, bachelor's degree plus 4 years, master's degree plus 2 years, or doctorate with bioprocessing experience; strong project management and GMP manufacturing background. Preferred: degrees in Chemical Engineering, Biology, or Biochemistry; expertise in cell culture, chromatography, filtration, buffer prep; technical data analysis; effective communicator; lean methodologies. HighValue: biologics (drug substance), manufacturing support, tech transfer, GMP environment, cross-functional collaboration, process development, operational excellence. WorkSetup: not specified; likely on-site at North Carolina plant with potential for cross-team interaction.