Downstream Drug Substance Associate — Flexible Shifts

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 71,000 - 96,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Flexible work model

Job summary

Amgen North Carolina seeks an Associate Manufacturing - Bulk Drug Substance Downstream to support the facility expansion and startup. You’ll work on downstream purification operations, including chromatography, filtration and tangential flow filtration, ensuring readiness and transfer to routine manufacturing.

In this 12‑hour shift environment, you’ll contribute to commissioning, qualification and early manufacturing activities, with emphasis on safety, quality and regulatory compliance, while

Qualifications

• Bachelor’s Degree or equivalent in a science/engineering field
• Associate’s Degree plus 6 months manufacturing/regulatory experience or High School/GED plus 2 years in regulated environment
• Experience in a cGMP manufacturing facility or biotechnology/pharma environment preferred

Responsibilities

• Perform hands‑on downstream manufacturing operations including setup, monitoring, cleaning and sanitization of equipment and areas
• Execute critical process tasks and monitor processes per approved procedures
• Complete Electronic Batch Records (EBRs) and perform in‑process sampling and analyses
• Identify and escalate safety, quality or schedule issues in a timely manner
• Support readiness, commissioning, qualification and early manufacturing activities

Skills

cGMP awareness

Quality documentation

Team collaboration

Education

Bachelor’s Degree

Associate’s Degree

High School/GED

Tools

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Amgen North Carolina seeks an Associate Manufacturing - Bulk Drug Substance Downstream to support the facility expansion and startup. You’ll work on downstream purification operations, including chromatography, filtration and tangential flow filtration, ensuring readiness and transfer to routine manufacturing.

In this 12‑hour shift environment, you’ll contribute to commissioning, qualification and early manufacturing activities, with emphasis on safety, quality and regulatory compliance, while