Manufacturing Associate, Bulk Drug Substance Upstream

HOWMIGHT YOU DEFY IMAGINATION?

Youveworked 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 missionto serve patients drives all that we do. It is key to our becoming one of the worlds 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. TheFleXBatch 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.

Letsdo this!

Lets change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The scheduleisa rotating 2-2-3,5:45AM-6:15PM(12-hour shift).Associates will be completing operations on the floor inourupstreamareaandare responsible forthe manufacturing of cGMP (Current Good Manufacturing Practices) drugsubstance.

With general direction, the Associate will support all floor operations in accordance withcGMPpractices.

Responsibilities will include...

• Completes workin 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

• Perform hands-on operations including set-up, cleaning, sanitization,monitoring of equipment and assigned area
• Run andmonitorcritical process tasks per assigned procedures
• Perform in-process sampling,operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
• Identify and escalation issues and concernsregardingdaily routine functions related to process and tasks; may engage with team on potential solutions
• Perform documentation for assigned functions (i.e., equipment logs, EBRs)
• Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), 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 weseekare team players with these qualifications.

• 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

• Completion of NCBio 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
• An ability todemonstratedesire and drive to learn and grow their understanding of operations and processes

As we work to develop treatments that take care of others, we also…