Downstream Drug Substance Manufacturing Associate (24/7 Ops)

Amgen SA; Holly Springs (NC); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Bonus program

Stock incentives

Paid time off

Flexible work models

Job summary

Amgen North Carolina (ANC) invites a qualified associate to join the bulk drug substance downstream team. You will contribute to purification processes, collaboration across functions, and ramp-up of operations in a new facility. The role involves equipment setup, process execution, and documentation of batch records.

The position emphasizes readiness, training, and continuous improvement to ensure manufacturing readiness as the plant scales to steady-state production.

Qualifications

• Bachelor’s Degree or higher in a related field preferred.
• Experience in a regulated manufacturing environment is a plus.
• Proficient in Microsoft Office and electronic systems (EBR/MES).

Responsibilities

• Perform hands-on downstream manufacturing operations including setup, operation, monitoring, cleaning, and sanitization.
• Run critical process tasks per approved procedures and complete Electronic Batch Records (EBRs).
• Identify and escalate safety, quality, or schedule issues.
• Support startup, commissioning, and qualification activities during facility expansion.

Skills

Verbal communication

Written communication

Team player

Microsoft Office

Education

Bachelor’s Degree

Associate’s Degree

High School/GED

Tools

EBR/MES

Delta V

Electronic Quality Systems

Microsoft Office

Job description

Amgen North Carolina (ANC) invites a qualified associate to join the bulk drug substance downstream team. You will contribute to purification processes, collaboration across functions, and ramp-up of operations in a new facility. The role involves equipment setup, process execution, and documentation of batch records.

The position emphasizes readiness, training, and continuous improvement to ensure manufacturing readiness as the plant scales to steady-state production.