Manufacturing Associate, Bulk Drug Substance Upstream - Days
Amgen
July 01, 2026
On-site
Holly Springs, NC
Operations
Manufacturing Associate, Bulk Drug Substance Upstream - Days (Rotating 2-2-3, 5:45AM-6:15PM; 12-hour shift)
What You Will Do
- Support upstream floor operations to manufacture cGMP drug substance in accordance with cGMP practices.
Responsibilities
Compliance:
- Follow cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
- Ensure proper gowning and aseptic techniques.
Process/Equipment/Facilities:
- Perform hands-on setup, cleaning, sanitization, monitoring of equipment and assigned areas.
- Run and monitor critical process tasks.
- Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records/EBRs).
- Identify and escalate issues; may help develop solutions.
- Complete documentation (e.g., equipment logs, EBRs).
- Collaborate with cross-functional teams (QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, Regulatory, etc.).
- Maintain an organized, clean, workable space.
What We Expect Of You
Basic Qualifications:
- High School/GED + 2 years manufacturing and/or other regulated environment experience; OR
- Associate’s Degree + 6 months manufacturing/regulated environment experience; OR
- Bachelor’s Degree.
Preferred Qualifications:
- Completion of NC BioWorks Certification Program.
- Experience in biotechnology/pharmaceutical regulated industry.
- Basic understanding and process experience in a cGMP manufacturing facility.
- Excellent verbal and written communication.
- Proficient Microsoft Office; knowledge of EBR/MES, Delta V, and Electronic Quality Systems.
- Drive to learn and grow understanding of operations and processes.
Benefits (as stated)
- Comprehensive benefits including retirement/savings, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); stock-based long-term incentives; time-off plans and bi-annual shutdowns; flexible work models where possible.
Apply
- Apply at careers.amgen.com.
What You Will Do
- Support upstream floor operations to manufacture cGMP drug substance in accordance with cGMP practices.
Responsibilities
Compliance:
- Follow cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
- Ensure proper gowning and aseptic techniques.
Process/Equipment/Facilities:
- Perform hands-on setup, cleaning, sanitization, monitoring of equipment and assigned areas.
- Run and monitor critical process tasks.
- Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records/EBRs).
- Identify and escalate issues; may help develop solutions.
- Complete documentation (e.g., equipment logs, EBRs).
- Collaborate with cross-functional teams (QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, Regulatory, etc.).
- Maintain an organized, clean, workable space.
What We Expect Of You
Basic Qualifications:
- High School/GED + 2 years manufacturing and/or other regulated environment experience; OR
- Associate’s Degree + 6 months manufacturing/regulated environment experience; OR
- Bachelor’s Degree.
Preferred Qualifications:
- Completion of NC BioWorks Certification Program.
- Experience in biotechnology/pharmaceutical regulated industry.
- Basic understanding and process experience in a cGMP manufacturing facility.
- Excellent verbal and written communication.
- Proficient Microsoft Office; knowledge of EBR/MES, Delta V, and Electronic Quality Systems.
- Drive to learn and grow understanding of operations and processes.
Benefits (as stated)
- Comprehensive benefits including retirement/savings, medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); stock-based long-term incentives; time-off plans and bi-annual shutdowns; flexible work models where possible.
Apply
- Apply at careers.amgen.com.