Associate Manufacturing - Bulk Drug Substance Downstream - Days

Amgen•Holly Springs, NC

2d•Onsite

About The Position

Amgen is seeking an Associate in the manufacturing organization at Amgen North Carolina (ANC) to support a facility expansion program and facility startup. This role will be part of a team responsible for downstream purification operations, including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill. The position involves partnering across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within a new facility. The role requires flexibility in working hours, including potential non-standard shifts, to support startup, commissioning, and qualification (C&Q), and engineering execution. Initially, the role will focus on a Monday-Friday schedule from 8 am to 5 pm during the startup phase. As the business transitions to manufacturing operations, the schedule will shift to a 12-hour 2-2-3 rotation (5:45 am to 6:15 pm) to support critical 24/7 operations. The role requires regular attendance and the ability to work assigned shifts, including inclement weather, holidays, and requested overtime. During early phases, the focus will be on operational readiness, training, and startup execution. As the facility reaches steady-state operations, the role will shift towards routine manufacturing execution and continuous improvement. The Associate will support all floor operations in accordance with cGMP practices.

Requirements

High School/GED + 2 years manufacturing and/or other regulated environment experience
Or Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
Or Bachelor’s Degree
Strong 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
Ability to work effectively in a team-based manufacturing environment

Nice To Haves

Completion of NC BioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical
Basic understanding and process experience in a cGMP manufacturing facility

Responsibilities

Execute work in accordance with established cGMP procedures and policies, including SOPs, MPs, JHAs, and applicable CFRs.
Ensure proper gowning and aseptic techniques are consistently followed.
Initiate and document manufacturing related deviations and quality events as trained.
Support investigations and corrective actions under guidance.
Maintain a strong culture of safety, quality, and compliance.
Support operational readiness and facility startup activities as part of the expansion program.
Participate in training, equipment familiarization, and procedure execution to enable startup.
Execute assigned readiness tasks supporting commissioning, qualification, and early manufacturing operations.
Follow defined workflows and procedures to support safe and compliant startup activities.
Provide operational feedback and escalate issues observed during startup execution.
Perform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and assigned areas.
Run and monitor critical process tasks per approved procedures.
Perform in-process sampling, operate analytical equipment, and complete Electronic Batch Records (EBRs).
Complete washroom activities for small- to large-scale manufacturing equipment.
Identify and escalate operational issues impacting safety, quality, or schedule.
Maintain an organized, clean, and compliant manufacturing environment.