Manufacturing Programs Senior Manager: New Product Introduction (NPI)

About the role

Join Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX Batch facility combines the latest in disposable technologies with traditional stainless-steel equipment for maximum operational flexibility. This facility features best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and integrates sustainability innovations to reduce carbon and waste, supporting Amgen's goal to be a carbon-neutral company by 2027.

In this role, you will serve as the key interface between GMP manufacturing teams at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANCs Manufacturing Support team, you will ensure new products are successfully introduced into the biologics manufacturing facility. This highly visible role drives cross-functional deliverables supporting tech transfers and offers opportunities to lead improvement initiatives for productivity and scheduling accuracy.

Responsibilities

• Act as the New Product Introduction (NPI) subject matter expert, coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and other teams to introduce new Drug Substance products and/or advanced technologies using project management tools.
• Apply rapid problem-solving capabilities to resolve technical challenges.
• Lead a team of NPI manufacturing specialists while fostering a culture that supports staff development.
• Serve as a technical expert who leads or participates in projects, ensuring production documents are accurate and up to date.
• Support Manufacturing in troubleshooting, problem-solving, and Root Cause Analyses (RCAs), as well as CAPA development to prevent error recurrence.
• Champion Lean Transformation and Operational Excellence (OE) initiatives, facilitate continuous improvement in the plant, and track progress at the plant level.

Requirements

We seek a manufacturing professional with a biologics Drug Substance (DS) manufacturing background, strong cross-functional project management and communication skills, and the following qualifications:

Basic Qualifications

• Doctorate degree and 2 years of biotechnology operations experience, or
• Master’s degree in chemistry, biology, or engineering and 6 years of biotechnology operations experience, or
• Bachelor’s degree and 8 years of biotechnology operations experience, or
• Associate’s degree and 10 years of biotechnology operations experience, or
• High school diploma/GED and 12 years of biotechnology operations experience.

Additionally, you must have a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience.

Preferred Qualifications

• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
• Excellent cross-functional project management, meeting facilitation, and technical writing skills.
• Experience in GMP manufacturing operations.
• Strong technical knowledge of drug substance processing in Cell Culture or Purification (chromatography, filtration, buffer compounding) and a broad understanding of related bioprocessing disciplines.
• Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, and modeling.
• Ability to effectively communicate complex technical information to 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.

Benefits

Amgen offers a comprehensive total rewards plan to support professional and personal growth, as well as well-being:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote work arrangements where possible.

Pay

The annual base salary range for this opportunity in the U.S. is provided below (specific range not listed in the original posting).