Manager - New Product Introduction (NPI) and Manufacturing Execution System (MES)

Role: Downstream Manager for New Product Introduction (NPI) and Manufacturing Execution Systems (MES) within Amgen’s GMP Drug Substance Supply. Primary objectives include leading a team responsible for integrating new products, advanced technologies, and electronic batch records into the plant operations, ensuring compliance, and driving operational excellence. Responsibilities encompass managing a team of specialists, coordinating with cross-functional units (Process Development, Engineering, Supply Chain, Quality), and championing lean transformation initiatives. The role requires ensuring audit readiness and regulatory compliance through maintained documentation and change control processes. Qualifications: Doctorate, or Master’s with 3+ years, Bachelor’s with 5+ years, or Associate’s with 10+ years of biotech operations experience, including direct team management or project leadership. Preferred skills include a background in Chemical or Biological Engineering, GMP operations, NPI experience, and familiarity with PAS X or Werum software. Knowledge of bioprocessing techniques—cell culture, chromatography, filtration—and operational excellence methodologies is advantageous. The position involves collaboration with regulatory bodies and internal teams, with the potential for cross-functional project management. Location is in Thousand Oaks, with a focus on GMP drug substance manufacturing for clinical and commercial supply, emphasizing biologics and cell/gene modalities in late-stage development or commercial phases.