Manufacturing Associate, Bulk Drug Substance Upstream - Days

Amgen•Holly Springs, NC

1d•$70,985 - $96,039•Onsite

About The Position

Amgen is building a new, advanced drug substance manufacturing plant in North Carolina, the FleX Batch facility. This facility will combine disposable technologies with traditional stainless-steel equipment for maximum operational flexibility. It will feature best-in-class drug substance manufacturing technologies with industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, aligning with Amgen's goal of being carbon-neutral by 2027. This role is for a Manufacturing Associate in the upstream area of this facility, working a rotating 12-hour shift schedule (2-2-3, 5:45 AM - 6:15 PM). The associate will be responsible for manufacturing cGMP drug substance, performing operations on the floor, and adhering to all safety and compliance regulations.

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 BioWorks Certification 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

Complete work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
Assure proper gowning and aseptic techniques are always followed.
Perform hands-on operations including set-up, cleaning, sanitization, and monitoring of equipment and assigned area.
Run and monitor critical process tasks per assigned procedures.
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]).
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, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
Maintain an organized, clean, and workable space.