Associate Manufacturing - Bulk Drug Substance - Services - Day Shift
Amgen
June 25, 2026
On-site
Holly Springs, NC
Operations
Responsibilities:
- Complete work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
- Assure proper gowning and aseptic techniques are always followed.
- Perform hands-on operations: set-up, cleaning, sanitization, and monitoring of equipment in assigned areas.
- Run and monitor critical process tasks per assigned procedures.
- Buffer and media preparation and transfer; weigh and dispense materials for buffer/media preparation.
- Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records/EBRs).
- Complete washroom activities: cleaning equipment (small to large scale).
- Identify and escalate issues/concerns; collaborate with teams on potential solutions.
- Maintain documentation (equipment logs, EBRs).
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in production activities.
- Maintain an organized, clean, workable space.
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 BioWork Certificate Program.
- Experience in regulated industry (biotech/pharma).
- Basic understanding and process experience in a cGMP manufacturing facility.
- Excellent verbal and written communication.
- Proficient Microsoft Office; experience with EBR/MES, Delta V, and Electronic Quality Systems.
- Desire and drive to learn and grow understanding of operations/processes.
Benefits (if applicable, as stated):
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending accounts); discretionary annual bonus; stock-based long-term incentives; time-off and bi-annual shutdowns; flexible work models where possible.
Application Instructions:
- Apply now.
- Complete work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
- Assure proper gowning and aseptic techniques are always followed.
- Perform hands-on operations: set-up, cleaning, sanitization, and monitoring of equipment in assigned areas.
- Run and monitor critical process tasks per assigned procedures.
- Buffer and media preparation and transfer; weigh and dispense materials for buffer/media preparation.
- Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records/EBRs).
- Complete washroom activities: cleaning equipment (small to large scale).
- Identify and escalate issues/concerns; collaborate with teams on potential solutions.
- Maintain documentation (equipment logs, EBRs).
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in production activities.
- Maintain an organized, clean, workable space.
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 BioWork Certificate Program.
- Experience in regulated industry (biotech/pharma).
- Basic understanding and process experience in a cGMP manufacturing facility.
- Excellent verbal and written communication.
- Proficient Microsoft Office; experience with EBR/MES, Delta V, and Electronic Quality Systems.
- Desire and drive to learn and grow understanding of operations/processes.
Benefits (if applicable, as stated):
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending accounts); discretionary annual bonus; stock-based long-term incentives; time-off and bi-annual shutdowns; flexible work models where possible.
Application Instructions:
- Apply now.