Associate Manufacturing - Bulk Drug Substance Downstream - Days

About the role

How might you defy imagination? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless‑steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature best‑in‑class drug substance manufacturing technologies with embedded Industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon‑neutral company by 2027.

Responsibilities

• Compliance & Quality: 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.
• Operational Readiness & Facility Startup: 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.
• Manufacturing Operations: 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.

Requirements

• High School/GED + 2 years manufacturing and/or other regulated environment experience
• Or Associates Degree + 6 months manufacturing and/or other regulated environment experience
• Or Bachelors Degree

Qualifications

• 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

Skills

• 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
• 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

Benefits

• Health and welfare plans for staff and eligible dependents
• Financial plans with opportunities to save toward retirement or other goals
• 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 (or sales‑based incentive for field sales)
• 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

Schedule

During early phases, the role follows a Monday‑Friday schedule from 8 am to 5 pm. As the business moves from commissioning and qualification to manufacturing operations, the position works a 12‑hour 2‑2‑