Manufacturing Associate, Bulk Drug Substance Upstream - Days
About The Position
Amgen is seeking a Manufacturing Associate for its newest and most advanced drug substance manufacturing plant, the FleX Batch facility in North Carolina. This facility combines disposable technologies with traditional stainless-steel equipment for maximum flexibility and integrates sustainability innovations. The role supports the facility expansion program and startup, focusing on manufacturing cell culture operations. This essential role will be part of a team responsible for manufacturing cell culture operations including seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation, while partnering across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within the new facility. The role requires flexibility in working hours to support startup, commissioning, and qualification (C&Q), and engineering execution, with a shift towards routine manufacturing execution and continuous improvement as the facility transitions to steady state operations. The Associate will support all floor operations in accordance with cGMP practices.
Requirements
- High School/GED + 2 years manufacturing and/or other regulated environment experience
- Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
- Bachelor’s Degree
Nice To Haves
- Completion of NC BioWork / BioWorks Certification Program
- Experience in a regulated industry such as biotechnology or pharmaceutical manufacturing
- Basic understanding of cGMP manufacturing environments
- Familiarity with EBR/MES, DeltaV, and electronic quality systems
- Strong verbal and written communication skills
- Demonstrated desire to learn, grow, and develop manufacturing skills
- Ability to work effectively in a team-based manufacturing environment
Responsibilities
- Execute work in accordance with established cGMP procedures and policies, including SOPs, MPs, JHAs, and applicable CFRs
- Ensure proper gowning and aseptic techniques are consistently followed
- Initiate and document manufacturing related deviations and quality events as trained
- Support investigations and corrective actions under guidance
- Maintain a strong culture of safety, quality, and compliance
- Support operational readiness and facility startup activities as part of the expansion program
- Participate in training, equipment familiarization, and procedure execution to enable startup
- Execute assigned readiness tasks supporting commissioning, qualification, and early manufacturing operations
- Follow defined workflows and procedures to support safe and compliant startup activities
- Provide operational feedback and escalate issues observed during startup execution
- Perform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and assigned areas
- Run and monitor critical process tasks per approved procedures
- Perform in-process sampling, operate analytical equipment, and complete Electronic Batch Records (EBRs)
- Complete washroom activities for small- to large-scale manufacturing equipment
- Identify and escalate operational issues impacting safety, quality, or schedule
- Maintain an organized, clean, and compliant manufacturing environment
Benefits
- Comprehensive employee benefits package
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
