Manufacturing Programs Senior Manager: New Product Introduction (NPI)
About The Position
Amgen is building a new, advanced drug substance manufacturing plant in North Carolina, the FleX Batch facility. This facility will combine disposable technologies with traditional stainless-steel equipment for operational flexibility and will feature industry 4.0 capabilities and sustainability innovations to reduce carbon and waste, aligning with Amgen's goal of carbon neutrality by 2027. The Manufacturing Programs Senior Manager for New Product Introduction (NPI) will be a key communicator between GMP manufacturing teams and Process Development scientific groups. This role is responsible for ensuring the successful introduction of new products into the manufacturing facility, driving cross-functional deliverables for tech transfers, and leading team improvement initiatives to enhance productivity and scheduling accuracy.
Requirements
- Doctorate degree and 2 years of biotechnology operations experience
- Master’s degree in chemistry, biology or engineering & 6 years of biotechnology operations experience
- Bachelor’s degree and 8 years of biotechnology operations experience
- Associate’s degree & 10 years of biotechnology operations experience
- High school diploma / GED & 12 years of biotechnology operations experience
- A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. This managerial experience may run concurrently with the required technical experience.
Nice To Haves
- 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 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.
Responsibilities
- Serve 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 into the plant using project management tools.
- Utilize rapid problem-solving capabilities to help the team resolve technical challenges.
- Lead a team of NPI manufacturing specialists, fostering a culture that helps staff thrive.
- Act as a technical expert to lead or participate in projects, ensuring production documents are accurate and up to date.
- Support Manufacturing in troubleshooting, problem-solving, and Root Cause Analysis (RCAs), and support CAPA development to prevent error recurrence.
- Champion Lean Transformation and Operational Excellence (OE) initiatives, facilitate continuous improvement in the plant, and track progress at a plant level.
Benefits
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
