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Associate Scientist, Process Development (Process Validation & Business Strategy)

United States, Holly Springs 97377.00 - 118653.00 USD / Year · Job Posted January 08, 2026
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Job Description

In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen’s FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes process development operation support, developing digital tools to support business processes, and support commercial development of Amgen’s pipeline. The role will be responsible for ensuring PD business strategy operations have appropriate digital tools to track operational metrics for safety, training, compliance, support business processes improvements, and the commercial development of the Amgen’s pipeline. In addition, the role will be responsible for supporting tech transfer activities as needed.

Job Responsibility

  • Lead and develop the Process Development safety, training, and compliance monitoring operation
  • Holistic Lab Execution Environment (HLEE) champion for the process development lab
  • Develop digital tools to improve business process efficiencies and identify bottlenecks within the process development operation
  • Develop digital tools to support process validation and process monitoring activities
  • Support and develop the Amgen North Carolina (ANC) PD DST knowledge management ecosystem, alignment of ANC PD business process to network practice, and optimizing the ANC PD business process
  • Provide process floor or lab support as required.

Requirements

  • Bachelor’s degree and 3 years of Process Development or Scientific experience
  • Master’s degree and 1 years of Process Development or Scientific experience
  • 2 – 4 years of experience in a Biotech/Pharma Process Development, MFG, QC, or laboratory role
  • Knowledge in broad aspects of biologics processing, for example cell culture, purification, analytical methods, or product quality attributes
  • Familiarity in operational aspects of process development lab or commercial biopharma manufacturing
  • Experienced with software such as Holistic Lab Execution Environment (HLEE), Tableau, MS PowerBI, spotfire, and/or databricks
  • Able to apply digital tool skills to solve business process issues and evaluate opportunities for process improvements
  • Excellent written and verbal communication
  • Be a self-starter with the ability to take on several projects at one time.

What we offer

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

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