Manager Manufacturing, New Product Introduction (NPI)

Role Summary

Manager for the New Product Introduction (NPI) Team in GMP Drug Substance Supply at Amgen North Carolina Manufacturing. Leads the NPI team responsible for introducing new products and advanced technologies into the plant, coordinating with Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality. Focuses on ensuring alignment, continuous improvement, and regulatory/compliance readiness in a GMP environment.

Responsibilities

• Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant, including hiring, training, oversight, performance evaluations, and development.
• Proactively assess the NPI team capabilities to meet evolving drug substance supply needs (e.g., resources, platform technical understanding, cross-functional alignment).
• Lead team meetings and drive alignment in business processes across the team.
• Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, 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, facilitating continuous improvement and tracking progress at the 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 by keeping NPI change controls up to date and supporting staff with audit or regulatory response strategy.
• Interact with management in planning, developing, and maintaining budget; assist in developing and maintaining department goals.
• Interact with regulatory agencies as needed.
• Engage staff and build relationships of trust and respect while driving team performance and continuous improvement; responsible for selection, training, evaluation, staff relations and staff development.
• Mentor and coach staff to uphold Amgen Values; develop and implement training plans to ensure staff are prepared and compliant.
• Other functional responsibilities may be assigned.

Qualifications

• Basic Qualifications:
• High school diploma / GED and 12 years of Manufacturing or Operations experience OR
• Associate’s degree and 10 years of Manufacturing or Operations experience OR
• Bachelor’s degree and 5 years of Manufacturing or Operations experience OR
• Master’s degree and 3 years of Manufacturing or Operations experience OR
• Doctorate degree

• Preferred Qualifications:
• 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 in lean manufacturing methodologies and operational excellence
• Experience in cross functional Project Management