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Specialist Manufacturing: Process Owner, Manufacturing Services

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Amgen

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Location:
United States , Holly Springs

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

107545.40 - 145502.60 USD / Year
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Job Description:

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch 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. This role will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC's Manufacturing Support team, this position is responsible for ownership of manufacturing services operations.

Job Responsibility:

  • Manufacturing services technical expert who leads weigh and dispensing operations, media and buffer solution preps and participates in projects, including aiding in commissioning and qualification and training staff on single-use technology, analytical equipment and processes
  • Coordinating with New Product Introduction (NPI) team, Manufacturing, Process Development, Supply Chain, 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)
  • Support Manufacturing in troubleshooting, problem solving and participating in deviation RCAs
  • Own and CAPA and Change Controls to prevent error recurrence and continuous improvement
  • Ensure that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and align with electronic batch records
  • Lead tabletop and water runs to test records and SOP updates prior to use before major changes
  • Provide hypercare support during first batch runs, PPQs, and/or during implementation of new technologies

Requirements:

Doctorate degree OR Master's degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience or Bachelor's degree and 5 years of biotechnology operations experience or Associate's degree & 10 years of biotechnology operations experience or High school diploma / GED & 12 years of biotechnology operations experience

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:
  • Health and welfare plans for staff and eligible dependents
  • Financial plans with opportunities to save towards retirement or other goals
  • Work/life balance
  • Career development opportunities
  • 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 and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

Additional Information:

Job Posted:
May 06, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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