Manufacturing Associate, Bulk Drug Substance Upstream - Days

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. 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 FleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch facility will feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

About the role

In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). You will support all floor operations in the upstream area, responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance. With general direction, you will ensure compliance with established procedures while collaborating with cross-functional teams.

Responsibilities

• Complete work in accordance with established cGMP procedures and policies (SOPs, Manufacturing Procedures, Job Hazard Analysis, Code of Federal Regulations) with strict adherence to safety and compliance.
• Ensure proper gowning and aseptic techniques are always 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).
• Identify and escalate issues and concerns regarding daily routine functions; may engage with the team on potential solutions.
• Perform documentation for assigned functions (e.g., equipment logs, EBRs).
• Collaborate as part of a cross-functional team (QA/QC, Facilities & Engineering, PPIC, Manufacturing, Process Development, Regulatory, etc.) in completing production activities.
• Maintain an organized, clean, and workable space.

Requirements

• High School/GED + 2 years of manufacturing and/or other regulated environment experience, or
• Associate’s Degree + 6 months of manufacturing and/or other regulated environment experience, or
• Bachelor’s Degree.

Qualifications

• Completion of NC BioWorks Certification Program.
• Experience in a regulated industry such as biotechnology or pharmaceuticals.
• Basic understanding and process experience in a cGMP manufacturing facility.
• Excellent verbal and written communication skills.
• Proficiency in Microsoft Office and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
• Demonstrated desire and drive to learn and grow understanding of operations and processes.

Schedule

Rotating 2-2-3 schedule: 5:45 AM – 6:15 PM (12-hour shift).

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on relevant skills, experience, and qualifications.

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.
• 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.