Senior Associate Manufacturing - Downstream-Nights - Holly Springs, NC

Job Description

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Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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.

In this dynamic role, you will be a Senior Associate in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12‑hour 2‑2‑3 schedule from 5:45pm to 6:15am. Associates will be executing operations on the floor in our downstream area and will be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.

With general direction, the Senior Associate is responsible for executing on‑the‑floor operations within manufacturing in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work the assigned 12‑hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.

• Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance
• Initiates quality non‑conformance (NC) reports
• Interacts with regulatory agencies as needed and guided
• Assures proper gowning and aseptic techniques are always followed

• Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)
• Performs hands‑on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set‑up, operation, cleaning, sanitization, monitoring of equipment and assigned area
• Runs and monitors critical process tasks per assigned procedures
• Performs in‑process sampling, operates analytical equipment, and completes process documentation (Electronic Batch Records)
• Completes washroom activities: cleaning equipment, small to large scale, used in production activities
• Initiates and owns manufacturing‑related process deviations
• Identifies, recommends, and implements innovative process improvements and optimizations related to daily routine functions
• Assists in the review of…