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 Amgen FleX Batch facility. 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. The position will transition from operational readiness and startup execution to routine manufacturing and continuous improvement. This role requires flexibility in working hours, including potential non-standard shifts, holidays, and overtime, especially during the startup and commissioning phases. Initially, the schedule will be Monday-Friday, 8 am-5 pm. As operations transition, it will move to a 12-hour 2-2-3 schedule (5:45 am-6:15 pm) to support 24/7 manufacturing. Regular attendance and the ability to work assigned shifts, including during inclement weather and holidays, are essential.
Requirements
- 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
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
- Support all floor operations in accordance with cGMP practices.
- 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
- Retirement and Savings Plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- 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
