Senior Associate, Downstream Biotech Manufacturing

Amgen; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Amgen is seeking a Senior Associate in Bulk Drug Substance Downstream to support 24/7 manufacturing operations in North Carolina. The role requires hands-on downstream biotech processing, cGMP compliance, and rigorous documentation.

You’ll work a 12-hour shift (5:45am–6:15pm) and collaborate with QA/QC, F&E, and PPIC to optimize production and safety. The ideal candidate will have a solid background in downstream purification operations and a proactive approach to continuous improvement within a

Qualifications

• Minimum education as listed: high school diploma or equivalent; additional degrees encouraged.
• Prefer experience in regulated manufacturing environments and biotech/pharma settings.
• Strong communication and collaboration across cross-functional teams required.

Responsibilities

• Operate downstream purification steps (Column Chromatography, TFF, viral filtration/inactivation).
• Perform on-the-floor tasks, ensure cGMP adherence, and complete process documentation (EBR).
• Support QA/QC, F&E, PPIC and other functions to meet production schedules.
• Drive safety, identify improvements, and escalate issues as needed.

Skills

Excellent verbal and written comms

Team player

Education

High School Diploma/GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Tools

Microsoft Office

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Amgen is seeking a Senior Associate in Bulk Drug Substance Downstream to support 24/7 manufacturing operations in North Carolina. The role requires hands-on downstream biotech processing, cGMP compliance, and rigorous documentation.

You’ll work a 12-hour shift (5:45am–6:15pm) and collaborate with QA/QC, F&E, and PPIC to optimize production and safety. The ideal candidate will have a solid background in downstream purification operations and a proactive approach to continuous improvement within a