Manufacturing Associate - Holly Springs, NC

Military Spouse Corporate Career Network•Holly Springs, NC

22h•Onsite

About The Position

This role is for a Manufacturing Associate in the Bulk Drug Substance Manufacturing Services team at Amgen North Carolina (ANC), supporting the ANC2 facility expansion and startup. The position is 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. The associate will partner across functions to support operational readiness, technology transfer, facility startup, and the ramp-up of manufacturing operations. The role requires flexibility in working hours, including non-standard shifts, to support startup, commissioning, and qualification (C&Q), and engineering execution. Initially, the schedule will be Monday through Friday, 8:00 a.m. to 5:00 p.m. As the business transitions to manufacturing operations, the role will move to a 12-hour, 2-2-3 schedule (5:45 a.m. to 6:15 p.m.) to support 24/7 operations. Regular attendance and the ability to work the assigned shift, including during inclement weather, holidays, and overtime, are essential. During the early project phases, the focus will be on operational readiness, training, procedure development, equipment and process familiarization, and startup execution. In steady-state operations, the role will shift to routine manufacturing execution, reliable delivery of materials and prepared solutions, equipment operation, cGMP documentation, and continuous improvement. The Associate will support Services floor operations in accordance with cGMP, applicable procedures, safety requirements, and production schedules.

Requirements

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

Nice To Haves

Completion of NC BioWork Certificate Program
Experience in a regulated industry such as biotechnology or pharmaceutical
Basic understanding and process experience in a cGMP manufacturing facility
Excellent verbal and written communication
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Responsibilities

Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
Assures proper gowning and aseptic techniques are always followed.
Performs hands-on operations including set-up, cleaning, sanitization, and monitoring of equipment in the assigned area.
Runs and monitors critical process tasks per assigned procedures.
Prepares and transfers buffers and media.
Weighs and dispenses materials for buffer and media preparation.
Performs in-process sampling, operates analytical equipment, and completes process documentation (Electronic Batch Records [EBRs]).
Completes washroom activities, including cleaning equipment used in production.
Identifies and escalates issues and concerns regarding daily routine functions related to process and tasks; may engage with the team on potential solutions.
Performs documentation for assigned functions (e.g., equipment logs, EBRs).
Collaborates as part of a cross-functional team (e.g., QA/QC, F&E, PPIC, Mfg., PD, Regulatory) in completing production activities.
Maintains an organized, clean, and workable space.