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. 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. 

Manufacturing Associate, Bulk Drug Substance Upstream - Days

Live 

What you will do 

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). The schedule is a rotating 2-2-3,  5:45AM-6:15PM (12-hour shift).  Associates will be completing operations on the floor in our upstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance. 

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

Responsibilities will include... 

Compliance: 

• Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance 

• Assure proper gowning and aseptic techniques are always followed 

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Process/Equipment/Facilities: 

• Perform hands-on operations including set-up, cleaning, sanitization, 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 escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions  

• Perform documentation for assigned functions (i.e., equipment logs, EBRs)