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Process Development Senior Engineer

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Amgen

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Location:
Singapore , Tuas

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

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Job Description:

Process Development Senior Engineer for Amgen Singapore Manufacturing. Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Process Development Senior Engineer in Amgen Singapore Manufacturing.

Job Responsibility:

  • Assume a Subject Matter Expert role within ASM Process Development for cell culture and/or purification commercial process support.
  • Act as Drug Substance Team Leader within the global Product Development Team (PDT)
  • providing stewardship of product lifecycle and process improvement.
  • Lead complicated investigations independently, providing concise communications to teams and leadership
  • Integrate trends, data and information into plans, deliverables and recommendations
  • Manage key projects to deliver site goals while meeting quality, schedule, and cost objectives.
  • lead productivity projects, process optimization, and product life cycle management.
  • Collaborate with cross-functional teams and network drug substance teams to resolve process challenges by applying advanced technical principles and concepts for troubleshooting.
  • Apply best practices to leverage data for more proactive and predictive approaches.
  • Support regulatory filings, audits and inspection, and other CMC activities (e.g author and review regulatory submissions and responses to questions as required).

Requirements:

  • Doctorate degree
  • Master’s degree and 2 years of directly related experience
  • Bachelor’s degree and 4 years of directly related experience
  • Diploma and 8 years of directly related experience
  • 6+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries
  • At least 4 years’ experience with regulated environments (i.e. cGMP) required
  • In depth cell culture and/or purification process knowledge, including single-use technologies and harvest technologies
  • Good understanding of process characterization and process scale up to resolve technical issues observed during transfer / manufacturing at large scale.
  • Experienced in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
  • Experienced in Technology Transfer of new process and technology to commercial site.
  • Strong communication skills (technical writing and verbal communication/presentation)
  • Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
  • Familiarity with documentation in a highly regulated environment
  • Ability to independently determine when additional resources are required to solve problems
  • Ability to provide solutions to a large variety of technical problems
  • Able to lead small team and lead projects
What we offer:
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Additional Information:

Job Posted:
December 18, 2025

Work Type:
On-site work
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