Manager Manufacturing, New Product Introduction - Downstream

About the role

Amgen is looking for a Manager for its New Product Introduction (NPI) team in GMP Drug Substance Supply, within Amgen North Carolina (ANC) Manufacturing and GMP Supply - Manufacturing Support. ANC is a supply facility for Amgen's pipeline products, producing drug substance for clinical trials and commercial supply using stainless steel and single-use equipment. The NPI team acts as the technical interface between plant manufacturing operations and Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering and Quality.

Key responsibilities

• Manage a team of NPI leads responsible for introducing new products and advanced technologies into the plant, including hiring, training, oversight, performance evaluations and development.
• Assess the team's capabilities against evolving drug substance supply needs and lead team meetings to align business processes.
• Coordinate with PD, DSTE, Supply Chain, Planning, Facilities & Engineering, Quality and Manufacturing on new products, process changes and improvements.
• Champion Lean Transformation and Operational Excellence initiatives and track progress at plant level.
• Work with Regulatory and Quality partners on change control records, and support audit and regulatory response strategies.
• Participate in budget planning and help develop department goals.
• Mentor staff, build relationships of trust and deliver training plans and programs.

Required profile

• Doctorate, or Master's degree plus 3 years of biotechnology or pharmaceutical manufacturing experience, or Bachelor's degree plus 5 years, or Associate's degree plus 10 years, or high school diploma plus 12 years of such experience.
• Experience directly managing people and/or leading teams, projects or programs.
• Preferred: degree in Chemical, Industrial, Biology or Biochemistry engineering; experience leading a team; experience in GMP operations and NPI; background in lean manufacturing and cross-functional project management.

Required skills

• Knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding).
• Ability to analyze technical data and communicate complex technical information internally and externally.
• Preferred: experience with PAS X and Werum software.

What we offer

• Health, dental, vision, life and disability insurance, and a retirement savings plan with company contributions.
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives.
• Time-off plans, bi-annual company-wide shutdowns and flexible work models where possible.