Specialist Manufacturing: New Product Introduction (NPI): CCMS/BOM
About The Position
Amgen is seeking a Specialist Manufacturing: New Product Introduction (NPI) to join their newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility combines disposable technologies with traditional stainless-steel equipment for maximum flexibility and integrates sustainability innovations. The Specialist will communicate and interface between GMP manufacturing teams and Process Development scientific groups, ensuring new products are successfully introduced into the facility. This is a highly visible role responsible for hosting cross-functional meetings to support tech transfer and driving team improvement initiatives for productivity and scheduling accuracy.
Requirements
- High school diploma/GED & 10 years of biotechnology operations experience OR Associate’s degree & 8 years of biotechnology operations experience OR Bachelor’s degree and 4 years of biotechnology operations experience OR Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR Doctorate degree
- 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 bioproprocessing.
- 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.
Nice To Haves
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
- Excellent cross-functional project management, meeting facilitation, and technical writing skills.
- Background in lean manufacturing methodologies and operational excellence.
Responsibilities
- New Product Introduction (NPI) lead 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.
- Technical expert who leads or participates in projects, ensuring that production documents are accurate and up to date.
- Support Manufacturing in troubleshooting, problem-solving and RCAs.
- Support CAPA development to prevent error recurrence.
- Owns New Product Introduction (NPI) Change Controls and collaborates with stakeholders to drive on-time completion.
- Responds to regulatory questions and/or audit findings.
- Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant, and tracks progress on 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
Mid Level
