Associate Manufacturing I - Downstream - Night Shift

Career Category

Manufacturing

Job Description

Join Amgen’s Mission of Serving Patients   

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.   

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.   

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.   

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.    

Associate Manufacturing (Night Shift) – Downstream  

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 initial schedule will be Monday-Friday, 8-hour days, and may include work from home. The schedule will transition to a 12-hour night shift as business needs dictate. Associates will be completing operations on the floor in our manufacturing services, upstream or downstream 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 

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]) 

• Complete washroom activities: cleaning equipment, small to large scale, used in production activities 

• Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions  

• Perform documentati