Manufacturing Associate; Nights

Position: Manufacturing Associate  (Nights)

Join to apply for the Manufacturing Associate (Nights) role at Amgen

Join to apply for the Manufacturing Associate (Nights) role at Amgen

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.

Manufacturing Associate

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 will be a 12-hour night shift from 5:45pm-6:15am on a 2-2-3 schedule rotation including every other weekend.

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...

• 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])
• 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)
• 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

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.

Basic Qualifications:

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

Preferred Qualifications :

• Completion of NC Bio Works Certification Program
• Experience in a regulated industry such as biotechnology or pharmaceutical
• Basic understanding and process experience in a cGMP manufacturing facility
• Basic knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
• 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 to demonstrate desire and drive to learn and grow their understanding of operations and processes

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding…