Manufacturing Associate, Bulk Drug Substance Upstream - Days
Amgen
August 15, 2026
Remote friendly (Holly Springs, NC)
United States
Operations
What You Will Do
- Operate on the manufacturing floor in the upstream area to manufacture cGMP drug substance.
- With general direction, support all floor operations in accordance with cGMP practices.
- Follow cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict safety and compliance.
- Ensure proper gowning and aseptic techniques.
- Perform hands-on set-up, 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 (Electronic Batch Records/EBRs).
- Identify and escalate issues/concerns and engage on potential solutions.
- Complete documentation for assigned functions (e.g., equipment logs, EBRs).
- Collaborate with cross-functional teams (QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, Regulatory) on production activities.
- Maintain an organized, clean, and workable space.
Basic Qualifications
- High School/GED + 2 years manufacturing and/or other regulated environment experience
OR
- Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
OR
- Bachelor’s Degree
Preferred Qualifications
- Completion of NC BioWorks Certification Program
- Experience in regulated industry (biotechnology/pharmaceutical)
- 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
- Desire and drive to learn and grow understanding of operations and processes
Apply now at careers.amgen.com
- Operate on the manufacturing floor in the upstream area to manufacture cGMP drug substance.
- With general direction, support all floor operations in accordance with cGMP practices.
- Follow cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict safety and compliance.
- Ensure proper gowning and aseptic techniques.
- Perform hands-on set-up, 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 (Electronic Batch Records/EBRs).
- Identify and escalate issues/concerns and engage on potential solutions.
- Complete documentation for assigned functions (e.g., equipment logs, EBRs).
- Collaborate with cross-functional teams (QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, Regulatory) on production activities.
- Maintain an organized, clean, and workable space.
Basic Qualifications
- High School/GED + 2 years manufacturing and/or other regulated environment experience
OR
- Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
OR
- Bachelor’s Degree
Preferred Qualifications
- Completion of NC BioWorks Certification Program
- Experience in regulated industry (biotechnology/pharmaceutical)
- 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
- Desire and drive to learn and grow understanding of operations and processes
Apply now at careers.amgen.com