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Specialist Manufacturing: NPI, Process Owner

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Amgen

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Location:
United States , Holly Springs

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Category:

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Contract Type:
Not provided

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Salary:

114990.00 - 139433.00 USD / Year

Job Description:

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.

Job Responsibility:

  • Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
  • Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of downstream unit operations
  • Host cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations
  • New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet)
  • Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
  • Support Manufacturing in troubleshooting, problem solving and RCAs
  • Support CAPA development to prevent error recurrence
  • Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion
  • Responds to regulatory questions and/or audit findings
  • Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date

Requirements:

  • High school diploma / GED & 10 years of biotechnology operations experience
  • Associate’s degree & 8 years of biotechnology operations experience
  • Bachelor’s degree and 4 years of biotechnology operations experience
  • Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
  • Doctorate degree
  • Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
  • Excellent cross-functional project management, meeting facilitation, and technical writing skills
  • Experience in Downstream GMP manufacturing operations
  • Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) 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

Nice to have:

  • Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
  • Excellent cross-functional project management, meeting facilitation, and technical writing skills
  • Experience in Downstream GMP manufacturing operations
  • Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) 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
What we offer:

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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