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Engineer, Process Development

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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:

95914.00 - 116069.00 USD / Year
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Job Description:

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleXBatch 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. In this role you will be a part of the Process Development Drug Substance Technology group at Amgen’s FleXBatch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.

Job Responsibility:

  • Apply a fundamental understanding of Downstream bioprocessing to support biologics technology transfer, process validation, and plant start-up
  • Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
  • Ensure safety and compliance of process development activities
  • Provide process on floor process support as required
  • Provide support for regulatory filing, inspection, and other CMC activities
  • Apply fundamental scientific principles to Biopharmaceutical manufacturing processes (downstream purification)in the development of process improvements, facility adaptations, and new process operations
  • Provide technical and on-the-floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing
  • Support the GMP manufacturing process evaluations and investigations
  • Develop novel mammalian next generation technologies to increase yield, process robustness, and enable new unit operations

Requirements:

  • High school diploma / GED and 8 years of process science or technology transfer experience
  • Associate’s degree and 6 years of process science or technology transfer experience
  • Bachelor’s degree and 4 years of process science or technology transfer experience
  • Master’s degree

Nice to have:

  • 2 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing
  • Chromatography, ultrafiltration and normal flow filtration operations experience
  • Chemical engineering principles for the scale up of unit operations from bench scale to commercial scale
  • Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
  • Excellent written and verbal communication
  • Experience developing and managing team training workflows and strategy
  • Demonstrated ability to work under moderate direction
  • Able to analyze and interpret data
  • Be a self-starter with the ability to take on several projects at one time

Additional Information:

Job Posted:
March 25, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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