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Amgen Logo Amgen · Manufacturing

Associate Manufacturing - Bulk Drug Substance Downstream - Days

United States, Holly Springs 70985.20 - 96038.80 USD / Year · Job Posted June 14, 2026
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Job Description

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch 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.

Job Responsibility

  • Completes work in accordance with established cGMP procedures and policies with strict adherence to safety and compliance
  • Assure proper gowning and aseptic techniques are always followed
  • Perform hands-on downstream bio-tech operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area
  • Run and monitor critical process tasks per assigned procedures
  • Perform in-process sampling, operate analytical equipment, and complete process documentation
  • Complete washroom activities: cleaning equipment, small to large scale, used in production activities
  • Initiate and own manufacturing related process deviations
  • Identify and escalate issues and concerns regarding daily routine functions related to process and tasks
  • may engage with team on potential solutions
  • Perform documentation for assigned functions
  • Collaborate as part of a cross-functional team in completing production activities
  • Maintain an organized, clean, and workable space

Requirements

  • High School/GED + 2 years manufacturing and/or other regulated environment experience
  • Or Associate's Degree + 6 months manufacturing and/or other regulated environment experience
  • Or Bachelor's Degree
  • Completion of NCBioWorks Certification Program
  • Experience in a regulated industry such as biotechnology or pharmaceutical
  • Basic understanding and process experience in a cGMP manufacturing facility
  • Excellent verbal and written communication
  • Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
  • An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

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
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • 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
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