Associate Manufacturing - Bulk Drug Substance Downstream - Days
About The Position
Amgen is building its newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility will combine disposable technologies with traditional stainless-steel equipment for maximum operational flexibility. It will feature best-in-class drug substance manufacturing technologies with industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, supporting Amgen's goal of being a carbon-neutral company by 2027. This role is an Associate in the manufacturing organization at Amgen North Carolina (ANC), supporting the facility expansion program and facility startup. The role will be part of a team responsible for downstream purification operations, including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill. This position will partner across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within the new facility.
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 BioWorks Certification Program
- Experience in a regulated industry such as biotechnology or pharmaceutical
- Basic understanding and process experience in a cGMP manufacturing facility
- Strong verbal and written communication
- Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
- An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes
- 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, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and 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
