Senior Associate Manufacturing - Downstream - Nights

Role Summary

Senior Associate Manufacturing - Downstream - Nights at Amgen North Carolina (ANC). This role supports 24/7 downstream manufacturing operations and is responsible for manufacturing cGMP drug substances on a 12-hour 2‑2‑3 shift from 5:45 pm to 6:15 am. The role works under general direction on‑floor, ensuring safe, compliant, and efficient production as part of Amgen’s drug substance manufacturing program.

• Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
• Initiates quality non‑conformance (NC) reports.
• Interacts with regulatory agencies as needed and guided.
• Ensures proper gowning and aseptic techniques are always followed.
• Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation).
• Performs hands‑on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing, among others) including setup, operation, 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 [E ]).
• Completes washroom activities: cleaning equipment, small to large scale, used in production activities.
• Initiates and owns manufacturing‑related process deviations.
• Identifies, recommends, and implements innovative process improvements and optimizations related to daily routine functions.
• Assists in the review of documentation for assigned functions (e.g., equipment logs, EBRs).
• Collaborates as part of a cross‑functional team (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
• Recognizes and elevates problems during daily operations.
• Participates in the implementation of programs and CAPAs with a focus on continuous improvement.
• Drives safety in all operations and escalates concerns as needed.
• Maintains an organized, clean, and workable space.

• Drafts and revises documents (SOPs, technical reports, and MPs).
• Interacts with management as an advisor in planning and escalating potential concerns with the schedule and/or process.

• Required:
  
  High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR
• Required:
  
  Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR
• Required:
  
  Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR
• Required:
  
  Master’s Degree
• Preferred:
  Completion of NC Bio Works Certification Program
• Preferred:
  Experience in biotechnology or pharmaceutical plant startup
• Preferred:
  Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
• Preferred:
  Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)

• Excellent verbal and written communication (technical) skills
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as E /MES, Delta V, and Electronic Quality Systems

• Must be able to work a 12‑hour shift (5:45 pm–6:15 am) on a 2‑2‑3 schedule to support 24/7 operations; includes potential inclement weather, some holidays, and overtime