Manager Manufacturing, New Product Introduction

• Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant
• Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs
• 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
• Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks 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
• Interacts with management in planning, developing, and maintaining budget
• Assist in developing and maintaining department goals
• Interact with regulatory agencies as needed
• Responsible for engaging staff and building 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 members to live by the Amgen Values
• Develop and implement trainings plans and programs, to ensure staff are prepared and compliant

• High school diploma / GED and 12 years of Manufacturing or Operations experience
• Associate’s degree and 10 years of Manufacturing or Operations experience
• Bachelor’s degree and 5 years of Manufacturing or Operations experience
• Master’s degree and 3 years of Manufacturing or Operations experience
• 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 in lean manufacturing methodologies and operational excellence
• Experience in cross functional Project Management

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards