Senior Associate – Bulk Drug Substance Downstream (12‑Hr Days)

Amgen SA; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

Amgen North Carolina is seeking a Senior Associate Manufacturing in Bulk Drug Substance Downstream for a 12-hour shift schedule from 5:45am to 6:15pm in a 24/7 operation. You will perform on-floor downstream purification operations, ensure cGMP compliance, and collaborate with QA/QC, F&E, PPIC, Mfg, and Regulatory to meet production goals.

The role emphasizes hands-on purification tasks, equipment setup, and documentation while supporting continuous improvement and safety in a fast-paced

Qualifications

• On-floor manufacturing operations in a cGMP environment.
• Documentation and compliance with SOPs, MPs, JHA, CFR.
• Collaborate across QA/QC, F&E, PPIC, Mfg, Regulatory.
• Understand downstream purification processes and equipment.

Responsibilities

• Execute on-floor downstream manufacturing tasks per SOPs and MPs.
• Maintain safety, cleanliness, and organized workspace.
• Initiate NC reports and CAPAs as needed.
• Collaborate with cross-functional teams to meet production goals.

Skills

cGMP knowledge

Quality documentation

Cross-functional collaboration

Education

High School Diploma/GED

Associate’s Degree

Bachelor’s Degree

Master's Degree

Tools

DeltaV

MES

Electronic Quality Systems

Job description

Amgen North Carolina is seeking a Senior Associate Manufacturing in Bulk Drug Substance Downstream for a 12-hour shift schedule from 5:45am to 6:15pm in a 24/7 operation. You will perform on-floor downstream purification operations, ensure cGMP compliance, and collaborate with QA/QC, F&E, PPIC, Mfg, and Regulatory to meet production goals.

The role emphasizes hands-on purification tasks, equipment setup, and documentation while supporting continuous improvement and safety in a fast-paced