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

Role Summary

Associate Manufacturing (Day Shift) in Manufacturing Services at Amgen North Carolina. This role supports 24/7 manufacturing operations on a 12-hour 2-2-3 schedule (5:45 a.m. to 6:15 p.m.), performing floor operations and manufacturing of cGMP drug substances. You will work under general direction, collaborating with cross-functional teams to ensure safe, compliant production.

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, monitoring of equipment in 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 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 (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
• Maintain an organized, clean, and workable space
• Demonstrate reliable attendance and be able to work the assigned 12-hour shift, including during inclement weather, some holidays, and overtime to support 24/7 operations

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, Delta V, and Electronic Quality Systems
• Preferred: An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Education

• High School diploma or GED
• Associate’s Degree
• Bachelor’s Degree

Additional Requirements

• Ability to work a 12-hour shift (5:45 a.m. – 6:15 p.m.), including inclement weather, some holidays, and overtime to support 24/7 operations