Associate Manufacturing - Bulk Drug Substance Upstream - Days

Amgen•Holly Springs, NC

3d•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 manufacturing cell culture operations, including seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration, and Centrifugation. The position involves partnering across functions to ensure operational readiness, technology transfer, and ramp-up of manufacturing operations within a new facility. The role requires flexibility in working hours, potentially including non-standard shifts, to support startup, commissioning, and qualification (C&Q), and engineering execution. Initially, the role will focus on operational readiness, training, and startup execution, with a shift towards routine manufacturing and continuous improvement as the facility transitions to steady-state operations. The Associate will support floor operations in accordance with cGMP practices.

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 / BioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical manufacturing
Basic understanding of cGMP manufacturing environments
Familiarity with EBR/MES, DeltaV, and electronic quality systems
Strong verbal and written communication skills
Demonstrated desire to learn, grow, and develop manufacturing skills
Ability to work effectively in a team-based manufacturing environment

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.