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Manufacturing Associate - Bulk Drug Substance Manufacturing Services

Job in Holly Springs, Wake County, North Carolina, 27540, USA
Listing for: Amgen SA
Full Time position
Listed on 2026-09-12
Job specializations:
  • Manufacturing / Production
    Production Associate / Production Line, Manufacturing & Industrial Operations, Pharmaceutical Manufacturing, Manufacturing Engineer
Salary/Wage Range or Industry Benchmark: 55000 - 75000 USD Yearly USD 55000.00 75000.00 YEAR
Job Description & How to Apply Below
Position: Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days

Join Amgen’s Mission of Serving Patients

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.

Manufacturing

Associate
- Bulk Drug Substance Manufacturing Services
- Days 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), supporting the ANC2 facility expansion and startup program. This essential role will be part of the Services team responsible for enabling manufacturing operations through weigh and dispense of raw materials, material receiving and handling, media, buffer, and solution preparation, and component preparation activities, including parts washing and autoclave operations.

You will also partner across functions to support successful operational readiness, technology transfer, facility startup, and the ramp‑up of manufacturing operations within the new facility.

This role may require work outside standard business hours, including non‑standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. During this phase of startup, you will be expected to work a Monday‑through‑Friday schedule from 8:00 a.m. to 5:00 p.m. As the business transitions from C&Q to manufacturing operations, this essential position will move to a 12‑hour, 2‑2‑3 schedule from 5:45 a.m. to 6:15 p.m., supporting critical 24/7 manufacturing operations.

Because Amgen relies on the regular attendance of all staff members to meet legitimate business needs, individuals in this role must be able to work their assigned 12‑hour shift, including during inclement weather, on some holidays, and during requested overtime in support of operations.

During the early phases of the project, this role will focus on operational readiness, training, procedure development, equipment and process familiarization, and startup execution. As the facility transitions to steady‑state operations, the role will shift toward routine manufacturing execution, reliable delivery of materials and prepared solutions, equipment operation, cGMP documentation, and continuous improvement.

With general direction, the Associate will support Services floor operations in accordance with current Good Manufacturing Practices (cGMP), applicable procedures, safety requirements, and established production schedules.

Responsibilities will include... Compliance:
  • Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing…
Position Requirements
10+ Years work experience
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