Associate Manufacturing – Downstream - Nights (Multiple Positions)

Role Summary

Associate Manufacturing – Downstream - Nights (Multiple Positions) at Amgen North Carolina (ANC). This essential role supports our 24/7 manufacturing operations and works a 12-hour 2-2-3 shift from 5:45pm to 6:15am. Associates will perform on-the-floor downstream operations and be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.

Responsibilities

• Completes 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 downstream bio-tech operations (Column Chromatography, Tangential Flow Filtration among others) including set-up, cleaning, sanitization, 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])
• Complete washroom activities: cleaning equipment, small to large scale, used in production activities
• Initiate and own manufacturing related process deviations
• 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 (Process Development), 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 OR Associate’s Degree + 6 months manufacturing and/or other regulated environment experience OR Bachelor’s Degree
• Preferred: Completion of NC BioWorks Certification 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