Manager Manufacturing, New Product Introduction (NPI)

Amgen•Holly Springs, NC

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –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. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Manager Manufacturing, New Product Introduction What you will do Let’s do this. Let’s change the world. In this vital role you will act as the Manager for the New Product Introduction (NPI) Team in GMP Drug Substance Supply. This position is within Amgen North Carolina (ANC) Manufacturing and GMP Supply - Manufacturing Support organization. ANC is a dynamic environment and an important supply facility for Amgen’s pipeline products. The GMP DSS plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. This NPI team is a key communication and technical interface between the GMP manufacturing operations teams in the plant and Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality. Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant. Includes hiring, training, oversight, performance evaluations, and development. Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs (ex. 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. 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 by ensuring NPI change controls are kept up to date and supporting staff with audit or regulatory response strategy. 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 Other functional responsibilities may be assigned

Requirements

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

Nice To Haves

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

Responsibilities

Act as the Manager for the New Product Introduction (NPI) Team in GMP Drug Substance Supply.
Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant. Includes hiring, training, oversight, performance evaluations, and development.
Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs (ex. 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.
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 by ensuring NPI change controls are kept up to date and supporting staff with audit or regulatory response strategy.
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
Other functional responsibilities may be assigned