Manufacturing Associate - Holly Springs, NC

Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days 

Live 

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 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 

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Process/Equipment/Facilities: 

Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment in assigned area 

Run and monitor critical process tasks per assigned procedures 

Buffer and Media preparation and transfer 

Weigh and dispense of materials to be used in the preparation of Buffers and Medias 

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 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