Senior Associate Upstream Manufacturing; Day Shift

Overview

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 biotech in our fight against the world’s toughest diseases. With focus on 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 lives. Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lie 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 disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and will integrate sustainability innovations to help Amgen become carbon-neutral by 2027.

Senior Associate Upstream Manufacturing (Day Shift)

What you will do:

In this dynamic role, you will be a Senior Associate in the manufacturing organization at Amgen North Carolina (ANC). The work schedule consists of 12-hour day shifts and includes working every other weekend, based on business requirements. You will execute operations on the floor in upstream manufacturing and be responsible for the manufacturing of cGMP drug substance. With general direction, you will execute on-the-floor operations in accordance with cGMP practices.

• Compliance:
  Complete work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
• Initiate quality non-conformance (NC) reports.
• Interact with regulatory agencies as needed and guided.
• 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 and monitor critical process tasks per assigned procedures.
• Perform in-process sampling, operate analytical equipment, and complete process documentation (E ).
• Complete washroom activities: cleaning equipment, small to large scale, used in production activities.
• Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions.
• Assist in the review of documentation for assigned functions (equipment logs, EBRs, ESPs).
• Collaborate as part of a cross-functional team (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
• Recognize and elevate problems during daily operations.
• Participate in the implementation of programs and CAPAs toward continuous improvement.
• Drive safety in all operations, and assist the manager in escalating concerns as needed.
• Maintain an organized, clean, and workable space.

• Draft and revise documents (SOPs, technical reports, MPs).
• Interact with management as an advisor in planning and in escalating potential concerns with the schedule and/or process.

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

• High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR
• Associates Degree + 2 years manufacturing and/or other regulated environment experience OR
• Bachelors Degree + 6 months manufacturing and/or other regulated environment experience OR
• Master's Degree

• Completion of NC Bio Work Certificate Program
• Experience in biotechnology or pharmaceutical plant start up
• Knowledge and process experience within…