Associate Manufacturing - Bulk Drug Substance Downstream

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 the 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.

Let’s do this! Let’s change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC) supporting the facility expansion program and facility startup. This essential role will be part of a team responsible for manufacturing downstream purification operations including column packing, column chromatography, TFF, viral filtration, virus inactivation, conjugation, and final fill, while partnering across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within the new facility.

This role may require work outside standard business hours, including non-standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. During this phase of the startup, you will be expected to work a Monday
- Friday schedule from 8am - 5pm. As the business moves from C&Q to manufacturing operations, this essential position will work on a 12-hour 2-2-3 schedule from 5:45 am to 6:15 pm supporting our critical 24/7 manufacturing operations. As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, this role must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our operations.

During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steady state operations, the role will shift toward routine manufacturing execution and continuous improvement.

With general direction, the Associate will support all floor operations in accordance with cGMP practices.

• 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

• 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 elevate issues observed during startup execution

• 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…