Manufacturing Associate, Bulk Drug Substance Upstream - Days
Amgen
August 15, 2026
On-site
Holly Springs, NC
Operations
Manufacturing Associate, Bulk Drug Substance Upstream - Days
What You Will Do
- Support facility expansion program and facility startup for ANC.
- Partner across functions for operational readiness, technology transfer, and ramp-up of cell culture manufacturing operations (seed train, SUBs, perfusion, RTF, stainless steel BRXs, depth filtration, centrifugation).
- Work outside standard hours as needed for startup, commissioning & qualification (C&Q), and engineering execution; Monday–Friday 8am–5pm initially, then a 12-hour 2-2-3 schedule (5:45am–6:15pm) for 24/7 operations.
- Support all floor operations in accordance with cGMP practices.
Key Responsibilities
Compliance & Quality
- Execute work per cGMP procedures/SOPs/MPs/JHAs and applicable CFRs.
- Follow gowning and aseptic techniques.
- Initiate/document deviations and quality events; support investigations and corrective actions.
- Maintain safety, quality, and compliance.
Operational Readiness & Facility Startup
- Support operational readiness, training, equipment familiarization, and startup execution.
- Execute readiness tasks for commissioning/qualification/early manufacturing; follow workflows and escalate issues.
Manufacturing Operations
- Perform hands-on setup, operation, monitoring, cleaning, sanitization.
- Run/monitor critical process tasks; perform in-process sampling.
- Operate analytical equipment; complete Electronic Batch Records (EBRs).
- Complete washroom activities; maintain organized, clean, compliant environment.
Qualifications
Basic Qualifications
- High School/GED + 2 years manufacturing and/or other regulated environment experience; OR
- Associate’s Degree + 6 months regulated manufacturing experience; OR
- Bachelor’s Degree.
Preferred Qualifications
- NC BioWork/BioWorks certification completion; regulated industry experience (biotech/pharma).
- Basic cGMP understanding; familiarity with EBR/MES, DeltaV, and electronic quality systems.
- Strong communication; desire to learn/grow; effective team-based environment.
Benefits (as listed)
- Retirement and Savings Plan (company contributions), medical/dental/vision, life & disability, flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; time-off plans and bi-annual shutdowns.
Apply now
- careers.amgen.com
What You Will Do
- Support facility expansion program and facility startup for ANC.
- Partner across functions for operational readiness, technology transfer, and ramp-up of cell culture manufacturing operations (seed train, SUBs, perfusion, RTF, stainless steel BRXs, depth filtration, centrifugation).
- Work outside standard hours as needed for startup, commissioning & qualification (C&Q), and engineering execution; Monday–Friday 8am–5pm initially, then a 12-hour 2-2-3 schedule (5:45am–6:15pm) for 24/7 operations.
- Support all floor operations in accordance with cGMP practices.
Key Responsibilities
Compliance & Quality
- Execute work per cGMP procedures/SOPs/MPs/JHAs and applicable CFRs.
- Follow gowning and aseptic techniques.
- Initiate/document deviations and quality events; support investigations and corrective actions.
- Maintain safety, quality, and compliance.
Operational Readiness & Facility Startup
- Support operational readiness, training, equipment familiarization, and startup execution.
- Execute readiness tasks for commissioning/qualification/early manufacturing; follow workflows and escalate issues.
Manufacturing Operations
- Perform hands-on setup, operation, monitoring, cleaning, sanitization.
- Run/monitor critical process tasks; perform in-process sampling.
- Operate analytical equipment; complete Electronic Batch Records (EBRs).
- Complete washroom activities; maintain organized, clean, compliant environment.
Qualifications
Basic Qualifications
- High School/GED + 2 years manufacturing and/or other regulated environment experience; OR
- Associate’s Degree + 6 months regulated manufacturing experience; OR
- Bachelor’s Degree.
Preferred Qualifications
- NC BioWork/BioWorks certification completion; regulated industry experience (biotech/pharma).
- Basic cGMP understanding; familiarity with EBR/MES, DeltaV, and electronic quality systems.
- Strong communication; desire to learn/grow; effective team-based environment.
Benefits (as listed)
- Retirement and Savings Plan (company contributions), medical/dental/vision, life & disability, flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; time-off plans and bi-annual shutdowns.
Apply now
- careers.amgen.com