Associate Manufacturing - (Bulk Drug Substance - Services) - Night Shift
Amgen
Associate Manufacturing (Bulk Drug Substance - Services) — Night Shift
What You Will Do
- Associate in the manufacturing organization at Amgen North Carolina (ANC)
- Supports critical 24/7 manufacturing operations; 12-hour 2-2-3 schedule from 5:45pm to 6:15am
- Completes operations on the floor in the manufacturing services area; responsible for manufacturing cGMP drug substances
- Support all floor operations per cGMP practices; work assigned shifts including inclement weather, some holidays, and requested overtime
Responsibilities Will Include...
Compliance
- Follow cGMP procedures/policies (SOPs, MPs, JHAs, CFR) with safety and compliance
- Assure proper gowning and aseptic techniques
Process/Equipment/Facilities
- Hands-on set-up, cleaning, sanitization, and equipment monitoring
- Run/monitor critical process tasks
- Buffer and media preparation and transfer; weigh and dispense materials
- In-process sampling, operate analytical equipment, and complete process documentation (EBRs)
- Washroom activities: clean equipment (small to large scale)
- Identify/escalate issues and concerns; collaborate on solutions
- Complete documentation (equipment logs, EBRs)
- 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 manufacturing/regulated environment experience
OR Bachelor’s Degree
Preferred Qualifications
- NC BioWork Certificate Program completion
- Regulated industry experience (biotech/pharma)
- cGMP manufacturing facility understanding/experience
- Excellent verbal and written communication
- Proficient Microsoft Office; experience with EBR/MES, Delta V, Electronic Quality Systems
- Desire and drive to learn/grow understanding of operations and processes
Benefits (explicitly listed)
- Comprehensive employee benefits package (retirement/savings, medical/dental/vision, life/disability, flexible spending)
- Discretionary annual bonus (or sales incentive plan for field sales reps)
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models (where possible)
- No relocation assistance
Application Instructions
- Apply now for a career that defies imagination.