Senior Associate, Downstream Biotech Manufacturing

Amgen; United States; Hybrid; USD 65,000 - 95,000; Full time

Job summary

Amgen North Carolina is seeking a Senior Associate for Downstream Manufacturing (Day Shift). You will operate on the manufacturing floor, performing cGMP compliant tasks and documentation.

The role may include initial 8-hour days with potential for home-based work, transitioning to 12-hour day or night shifts as needed. You will work within Manufacturing Services, ensuring clean, compliant operations, supporting continuous improvement and safety.

Qualifications

• High school diploma or higher with manufacturing/regulatory experience.
• cGMP knowledge and regulated environment experience preferred.
• Strong communication and teamwork skills.

Responsibilities

• Execute on-floor manufacturing operations in line with cGMP procedures.
• Perform setup, cleaning, and sanitization; monitor equipment and area.
• Run critical process tasks and document results (EBR).
• Review documentation and participate in CAPAs and continuous improvement.
• Collaborate with QA/QC, Facilities & Engineering, PPIC, Mfg., and Regulatory teams.

Skills

cGMP knowledge

Strong communication

Team collaboration

Problem solving

Education

High School Diploma / GED + 4 years manufacturing experience

Associate's Degree + 2 years manufacturing experience

Bachelor's Degree + 6 months manufacturing experience

Master's Degree

Tools

EBR/MES

Delta V

Electronic Quality Systems

Job description

Amgen North Carolina is seeking a Senior Associate for Downstream Manufacturing (Day Shift). You will operate on the manufacturing floor, performing cGMP compliant tasks and documentation.

The role may include initial 8-hour days with potential for home-based work, transitioning to 12-hour day or night shifts as needed. You will work within Manufacturing Services, ensuring clean, compliant operations, supporting continuous improvement and safety.