Associate Manufacturing - Bulk Drug Substance Downstream - Days Job at Amgen, Holly Springs, NC

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  • Amgen
  • Holly Springs, NC

Job Description

Amgen seeks an Associate Manufacturing professional to support downstream purification operations at a new bulk drug substance facility in North Carolina. The role involves manufacturing execution, facility startup activities, and compliance with cGMP practices, with potential for shift work including 12-hour rotations.

Responsibilities

  • Execute downstream purification operations including column chromatography, viral filtration, and final fill
  • Support facility startup, commissioning, and qualification activities with operational readiness tasks
  • Perform hands-on equipment setup, operation, monitoring, cleaning, and sanitization
  • Complete in-process sampling, operate analytical equipment, and document work in Electronic Batch Records
  • Initiate and document manufacturing deviations and quality events in accordance with cGMP procedures

Requirements

  • High school diploma/GED plus 2 years manufacturing or regulated environment experience
  • Or Associate's degree plus 6 months manufacturing or regulated environment experience
  • Or Bachelor's degree
  • Experience in biotechnology or pharmaceutical regulated industry preferred
  • Knowledge of cGMP manufacturing facilities and aseptic techniques
  • Proficiency with Microsoft Office and electronic systems such as EBR/MES or Delta V

Job Tags

Work at office, Shift work

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