Manufacturing Associate, Bulk Drug Substance Upstream

Manufacturing Associate, Bulk Drug Substance Upstream - Days What you will do

In this dynamic role you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The schedule is a rotating 2‑2‑3, 5:45 AM–6:15 PM M (12‑hour shift). Associates will complete operations on the floor in our upstream area and are responsible for the manufacturing of cGMP drug substance.

• Complete work in accordance with cGMP procedures and policies with strict adherence to safety and compliance.
• Assure proper gowning and aseptic techniques are always followed.
• Perform hands‑on operations including set‑up, cleaning, sanitization, and monitoring of equipment and assigned area.
• 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 regarding daily routine functions and engage the team in potential solutions.
• Perform documentation for assigned functions (equipment logs, EBRs).
• Collaborate as part of a cross‑functional team (QA/QC, Facilities & Engineering, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
• Maintain an organized, clean, and workable space.

We are all different, yet we all use our unique contributions to serve patients. The hard‑working professionals we seek are team players with these qualifications.

• 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.

• Completion of 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.
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as E /MES, Delta V, and Electronic Quality Systems.
• Ability to demonstrate desire and drive to learn and grow understanding of operations and processes.

We offer the following benefits as part of the Total Rewards Plan:

• 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, or for field sales representatives, a sales-based incentive plan.
• 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.

Amgen is an Equal Opportunity employer and will consider you without regard to your 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, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.