Manufacturing Associate, Bulk Drug Substance Upstream - Days

Amgen•Holly Springs, NC

1d•$70,985 - $96,039•Onsite

About The Position

Amgen is seeking a Manufacturing Associate for its newest and most advanced drug substance manufacturing plant, the FleX Batch facility. This facility combines disposable technologies with traditional stainless-steel equipment for maximum 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, supporting Amgen's goal of being a carbon-neutral company by 2027. The role involves hands-on operations in the upstream area for the manufacturing of cGMP drug substance, supporting all 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
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

Nice To Haves

Completion of NC BioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical

Responsibilities

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.
Assures proper gowning and aseptic techniques are always followed.
Performs hands-on operations including set-up, cleaning, sanitization, and monitoring of equipment and assigned area.
Runs and monitors critical process tasks per assigned procedures.
Performs in-process sampling, operates analytical equipment, and completes process documentation (Electronic Batch Records [EBRs]).
Identifies and escalates issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions.
Performs documentation for assigned functions (i.e., equipment logs, EBRs).
Collaborates 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.
Maintains an organized, clean, and workable space.