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Senior Associate Manufacturing - Bulk Drug Substance Downstream

United States, Holly Springs Employment contract 86048.05 - 116417.95 USD / Year · Job Posted May 06, 2026
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Job Description

Let’s do this. Let’s change the world. In this dynamic role, you will be a Senior Associate in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45am to 6:15pm. Associates will be executing operations on the floor in our downstream area and will be responsible for the manufacturing of cGMP drug substances.

Job Responsibility

  • Execute on-the-floor operations within manufacturing in accordance with cGMP practices
  • Complete work in accordance with established cGMP procedures and policies with strict adherence to safety and compliance
  • Initiate quality non-conformance (NC) reports
  • Assure proper gowning and aseptic techniques are always followed
  • Perform hands-on downstream biotech operations including set-up, operation, 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
  • Initiate and own manufacturing related process deviations
  • Identify, recommend, and implement innovative process improvements and optimizations
  • Assist in the review of documentation for assigned functions
  • Collaborate as part of a cross-functional team in completing production activities
  • Responsible for recognizing and elevating problems during daily operations
  • Participate in the implementation of programs and CAPAs
  • Drive safety in all operations
  • Maintain an organized, clean, and workable space
  • Draft and revise documents
  • Interact with management as an advisor in planning and in escalating potential concerns

Requirements

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR Master's Degree

Nice to have

  • Completion of NC BioWorks Certification Program
  • Experience in biotechnology or pharmaceutical plant start up
  • Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
  • Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
  • Excellent verbal and written communication (technical) skills
  • Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

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