Associate Manufacturing - Bulk Drug Substance Downstream - Days
About The Position
Amgen is seeking an Associate in the manufacturing organization at Amgen North Carolina (ANC) to support critical 24/7 manufacturing operations. This role works a 12-hour 2-2-3 schedule from 5:45 am to 6:15 pm in the downstream area, responsible for the manufacturing of cGMP drug substances. The Associate will support all floor operations in accordance with cGMP practices, requiring regular attendance and the ability to work assigned shifts, including holidays and overtime. This position is part of Amgen's newest and most advanced drug substance manufacturing plant, the FleX Batch facility, which combines disposable technologies with traditional equipment and integrates sustainability innovations.
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
- Excellent 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
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
Responsibilities
- Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
- Assures proper gowning and aseptic techniques are always followed.
- Performs hands-on downstream bio-tech operations (Column Chromatography, Tangential Flow Filtration among others) including set-up, cleaning, sanitization, and monitoring of equipment and assigned area.
- Runs and monitors critical process tasks per assigned procedures.
- Performs in-process sampling, operates analytical equipment, and completes process documentation (Electronic Batch Records [EBRs]).
- Completes washroom activities: cleaning equipment, small to large scale, used in production activities.
- Initiates and owns manufacturing-related process deviations.
- Identifies and escalates issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions.
- Performs documentation for assigned functions (i.e., equipment logs, EBRs).
- Collaborates as part of a cross-functional team (i.e., QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
- Maintains an organized, clean, and workable space.
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
