Associate Manufacturing (Night Shift) - Manufacturing Services - Multiple Positions

Role Summary

Location: Amgen North Carolina (ANC). This role supports 24/7 drug substance manufacturing on a 12-hour 2-2-3 shift (5:45 PM–6:15 AM) in the Manufacturing Services area. You will perform on-floor operations to manufacture cGMP drug substances, following established cGMP procedures and collaborating with cross-functional teams to ensure safe, compliant, and efficient production.

Responsibilities

• Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with 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 in the assigned area.
• Run and monitor critical process tasks per assigned procedures.
• Buffer and media preparation and transfer.
• Weigh and dispense materials to be used in the preparation of buffers and media.
• Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]).
• Complete washroom activities: cleaning equipment, small to large-scale, used in production activities.
• Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; engage with the team on potential solutions.
• Perform documentation for assigned functions (equipment logs, EBRs).
• Collaborate as part of a cross-functional team (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
• Maintain an organized, clean, and workable space.

Qualifications

• Required: High School/GED + 2 years manufacturing and/or other regulated environment experience.
• Required: Associate’s Degree + 6 months manufacturing and/or other regulated environment experience.
• Required: Bachelor’s Degree.
• Preferred: Completion of NC BioWork Certificate Program.
• Preferred: Experience in a regulated industry such as biotechnology or pharmaceutical.
• Preferred: Basic understanding and process experience in a cGMP manufacturing facility.
• Preferred: Excellent verbal and written communication.
• Preferred: Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
• Preferred: Ability to demonstrate desire and drive to learn and grow their understanding of operations and processes.