Manufacturing Associate, Bulk Drug Substance Upstream

At Amgen, our shared mission—to serve patients—drives everything we do. We are a world‑leading biotechnology company, reaching over 10 million patients worldwide, and we invite you to contribute to groundbreaking work at our newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility.

Location:

Amgen North Carolina (ANC) – 5:45 AM to 6:15 PM rotating 2‑2‑3 schedule (12‑hour shift).

As an Associate in the manufacturing organization, you will support all floor operations in accordance with cGMP practices, ensuring safe, efficient, and compliant production of drug substance.

• Complete work in accordance with cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
• Assure proper gowning and aseptic techniques are followed.
• Perform hands‑on operations including set‑up, cleaning, sanitization, and monitoring of equipment and assigned areas.
• Run and monitor critical process tasks per assigned procedures.
• Perform in‑process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]).
• Identify and elevate issues and concerns related to daily routine functions; collaborate with cross‑functional teams (QA/QC, Facilities & Engineering, PPIC, Process Development, Regulatory, etc.) on potential solutions.
• Maintain an organized, clean, and workable space; keep equipment logs and other documentation as required.

• High School or GED with 2+ years of manufacturing and/or regulated environment experience.
• Associate’s Degree with 6 months of manufacturing and/or regulated environment experience.
• Bachelor’s Degree in a related field.

• Completion of the NC Bio Works Certification Program.
• Experience in a regulated industry such as biotechnology or pharmaceutical.
• Basic understanding and process experience in a cGMP manufacturing facility.
• Excellent verbal and written communication skills.
• Proficiency with Microsoft Office and electronic systems such as E /MES, Delta V, and Electronic Quality Systems.
• Desire and drive to learn and grow understanding of operations and processes.

• Comprehensive employee benefits package, including a retirement and savings plan with generous company contributions.
• Group medical, dental, and vision coverage; life and disability insurance.
• Flexible spending accounts and a discretionary annual bonus program.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
• Flexible work models where possible, including remote work arrangements.

Amgen is an Equal Opportunity Employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process and to perform essential job functions.