Manager Manufacturing, Product Introduction; NPI

Manager Manufacturing, New Product Introduction (NPI)

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At Amgen, we strive to serve patients living with serious illnesses. Since 1980, we’ve pioneered the world of biotech in our fight against the toughest diseases. Focusing on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award‑winning culture is collaborative, innovative, and science‑based. Amgen is committed to building a world‑class manufacturing plant—the Amgen FleX Batch facility—that integrates the latest "single‑use" technologies with traditional stainless steel equipment, sustainability innovations, and Industry 4.0 capabilities to support our goal of becoming carbon‑neutral by 2027.

• Directly manage a team of NPI leads responsible for the introduction of new products and/or advanced technologies into the plant, including hiring, training, oversight, performance evaluations, and development.
• Proactively assess the NPI team’s capabilities to meet evolving drug substance supply needs (resources, platform technical understanding, cross‑functional alignment).
• Lead team meetings and drive alignment in business processes across the team.
• Coordinate with Process Development, Drug Substance Technologies & Engineering, Supply Chain, Planning, Facilities & Engineering, and Quality as well as Manufacturing for the introduction of new products, process changes, and improvements, and/or advanced technologies into the plant.
• Champion Lean Transformation and OE initiatives, facilitate continuous improvement in the plant, and track progress on a plant level.
• Collaborate with Regulatory and Quality partners to ensure compliance of team change control records/documents and respond to regulatory questions and/or audit findings.
• Drive a culture of inspection readiness across the team by ensuring NPI change controls are kept up to date and supporting staff with audit or regulatory response strategy.
• Interact with management in planning, developing, and maintaining budgets.
• Assist in developing and maintaining departmental goals.
• Interact with regulatory agencies as needed.
• Build relationships of trust and respect while driving team performance and continuous improvement.
• Responsible for staff selection, training, evaluation, relations, and development.
• Mentor and coach staff members to live by the Amgen values.
• Develop and implement training plans and programs to ensure staff are prepared and compliant.
• Other functional responsibilities may be assigned.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a dedicated leader with the following qualifications.

• High school diploma / GED and 12 years of Manufacturing or Operations experience OR
• Associates degree and 10 years of Manufacturing or Operations experience OR
• Bachelors degree and 5 years of Manufacturing or Operations experience OR
• Masters degree and 3 years of Manufacturing or Operations experience OR
• Doctorate degree

• Degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry.
• Experience leading/managing a team of direct reports.
• Experience with PAS X, Werum software.
• Experience in GMP operations, including New Product Introduction (NPI).
• Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing.
• Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms.
• Ability to coach, mentor and/or cross‑train colleagues within core technical areas.
• Background…