Senior Associate Manufacturing - Bulk Drug Substance Upstream (Days)

About the role

Amgen is hiring a Senior Associate Manufacturing for its bulk drug substance upstream operations at Amgen North Carolina (ANC), supporting 24/7 manufacturing. The role works a 12-hour 2-2-3 shift from 5:45am to 6:15pm and requires regular attendance, including during bad weather, some holidays and requested overtime. It sits in the new FleX Batch facility, which combines disposable technologies with stainless steel equipment.

Key responsibilities

• Execute on-the-floor operations in the upstream area according to cGMP practices, with general direction
• Follow SOPs, MPs, JHAs and CFR requirements, and ensure proper gowning and aseptic technique
• Start quality observations (discrepancies, deviations, testing results analysis) and support or lead investigations
• Set up, clean and sanitize equipment, run and monitor critical processes, perform in-process sampling and operate analytical equipment
• Complete process documentation in Electronic Batch Records (EBR)
• Recommend process improvements, review documentation (equipment logs, EBRs, ESPs) and participate in CAPA programs
• Work with QA/QC, Facilities & Engineering, PPIC, Process Development and Regulatory teams, escalate safety concerns and keep the workspace clean and organized
• Draft and revise SOPs, technical reports and MPs, and advise management on scheduling and process issues

Required profile

• High school diploma/GED plus 4 years of manufacturing or regulated environment experience, or
• Associate's degree plus 2 years, or
• Bachelor's degree plus 6 months, or
• Master's degree preferred
• Ability to work the 12-hour shift regularly, including overtime

Required skills

• Basic understanding of upstream operations (vial thaw, inoculation/cell expansion, single-use and production bioreactors, ATF, harvest centrifuge, depth filtration)
• Knowledge of cGMP manufacturing environments
• Technical verbal and written communication
• Microsoft Office; knowledge of EBR/MES, Delta V and electronic quality systems is preferred

What we offer

• Salary range of $86,048 to $116,417
• Total rewards plans aligned with local industry standards
• Support for professional and personal growth