Associate Manufacturing – Downstream - Nights (Multiple Positions)
Amgen
Associate Manufacturing – Downstream - Nights (Multiple Positions)
What You Will Do:
- Work 12-hour 2-2-3 schedule from 5:45pm to 6:15am supporting 24/7 operations.
- Complete hands-on downstream cGMP drug substance manufacturing operations.
- Follow cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict safety/compliance.
- Ensure proper gowning and aseptic techniques.
- Perform downstream biotech operations (e.g., Column Chromatography, Tangential Flow Filtration): set-up, cleaning, sanitization, monitoring.
- Run/monitor critical process tasks; perform in-process sampling and operate analytical equipment.
- Complete process documentation (Electronic Batch Records/EBRs) and equipment logs.
- Complete washroom activities (cleaning equipment at small to large scale).
- Initiate and own manufacturing-related process deviations; identify/escalate issues and concerns.
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg., PD, Regulatory).
- Maintain organized, clean, workable space.
Basic Qualifications:
- High School/GED + 2 years manufacturing and/or regulated environment experience; or Associate’s Degree + 6 months; or Bachelor’s Degree.
Preferred Qualifications:
- Completion of NC BioWorks Certification Program.
- Experience in biotech/pharma or other regulated industry.
- Basic understanding/process experience in a cGMP facility.
- Excellent verbal/written communication.
- Proficient Microsoft Office; knowledge of EBR/MES, Delta V, Electronic Quality Systems.
- Ability/desire to learn and grow.
Benefits (explicitly stated):
- Comprehensive employee benefits package (medical/dental/vision, life/disability, flexible spending, retirement/savings with company contributions), discretionary annual bonus, stock-based long-term incentives, award-winning time-off and bi-annual shutdowns, flexible work models where possible.
Application Instructions:
- Apply now via careers.amgen.com.