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Amgen Logo Amgen · -

Engineer - Process Development

United States, Cambridge 88281.00 - 119439.00 USD / Year · Job Posted May 29, 2026
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Job Description

In this vital role you will be responsible for supporting process development and technology transfer of Amgen's drug substance synthetics processes across all phases of development and commercialization. Chemical engineering fundamentals will be applied to generate process understanding and implement scalable drug substance processes that deliver Amgen's pipeline. The Engineer will partner with a multi-functional group of engineers and scientists through the process development cycle at Amgen develop and optimize synthetic unit operations aligned for the intended phase of technology transfer and commercial support. This includes experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and in-plant support of production operations during process execution and equipment commissioning.

Job Responsibility

  • Evaluate, select and execute standard experimental, modeling and engineering techniques for process optimization, characterization, and scale up of synthetic active pharmaceutical ingredients in state-of-the-art facilities
  • Initiate and complete technical tasks in lab, kilo/pilot plant, and manufacturing environments
  • Author documents for process understanding, transfer, risk assessment, facility fit, and development/characterization
  • Function as a technical expert to equipment or systems regarding troubleshooting operations
  • Frequently become actively involved in daily production or development operations when required to meet schedules or to resolve complex problems
  • Routinely monitor manufacturing processes for performance indicators and operations
  • Suggest problem resolution, provide troubleshooting guidance and recommend process improvements
  • Apply engineering principles and statistical analysis, including design of experiments, in order to solve processing issues and evaluate opportunities for process improvements
  • Communicate and collaborate with Manufacturing, Process Development, and Quality departments
  • Contribute to key regulatory and quality activities such as non-conformance, process performance qualification and continued process verification

Requirements

  • Master's degree
  • Bachelor's degree and 2 years of Engineering or Operations experience
  • Associate's degree and 6 years of Engineering or Operations experience
  • High school diploma / GED and 8 years of Engineering or Operations experience

Nice to have

  • Academic background in Chemical Engineering
  • 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of synthetic manufacturing processes
  • Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
  • Basic understanding of cGMP requirements
  • Experience building and utilizing first principal models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms
  • Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
  • Background in statistical analysis/DoE
  • Working knowledge of standard plant operations and safety practices
  • Excellent project management skills
  • Strong verbal communication and presentation skills

What we offer

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
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