Associate Manufacturing (Day Shift) - Multiple Positions

Role Summary

Associate Manufacturing (Day Shift) – Multiple Positions. This role supports Amgen's 24/7 drug substance manufacturing operations at Amgen North Carolina (ANC). The position is on the floor in the manufacturing services area, performing cGMP drug substance manufacturing on a 12-hour 2-2-3 schedule (5:45 am to 6:15 pm). The role requires adherence to cGMP procedures and collaboration with cross-functional teams to ensure safe, compliant production.

Responsibilities

• 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 used in the preparation of buffers and medias.
• 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; 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 (QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities.
• Maintain an organized, clean, and workable space.
• Work a 12-hour 2-2-3 schedule (5:45 am to 6:15 pm) to support 24/7 operations; must be available for inclement weather, some holidays, and overtime.
• Complete 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.

Qualifications

• Required: High School/GED + 2 years manufacturing and/or other regulated environment experience OR
• Required: Associate’s Degree + 6 months manufacturing and/or other regulated environment experience OR
• 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, DeltaV, and Electronic Quality Systems
• Preferred: An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes