Downstream Manufacturing Senior Associate - Flexible/Remote

Amgen; Holly Springs (NC); Hybrid; USD 75,000 - 110,000; Full time

Benefits offered by this job

Flexible work arrangements

Competitive benefits package

Job summary

Amgen North Carolina is seeking a Senior Associate Manufacturing - Bulk Drug Substance Downstream to support the facility expansion, startup, and 24/7 operations. You will execute downstream purification steps and collaborate with QA/QC, Facilities & Engineering, PPIC, and Regulatory teams to ensure readiness and continuous improvement.

This role involves rotating 12-hour shifts during startup transitioning to steady-state manufacturing, and may require overtime to meet production schedules.

Qualifications

• Requires familiarity with cGMP procedures and policies.
• Experience in regulated manufacturing environments preferred.
• Strong collaboration across QA/QC, Facilities & Engineering, PPIC and Regulatory teams.

Responsibilities

• Support facility expansion and startup readiness for downstream purification operations.
• Perform column packing, chromatography, TFF, viral filtration, viral inactivation, conjugation and fill operations.
• Participate in commissioning, qualification, and startup activities; provide feedback for safe and efficient manufacturing.
• Maintain clean, organized work areas and ensure regulatory compliance and proper documentation.

Skills

Team player

Strong communication

Problem solving

Attention to detail

Education

High School Diploma/GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Job description

Amgen North Carolina is seeking a Senior Associate Manufacturing - Bulk Drug Substance Downstream to support the facility expansion, startup, and 24/7 operations. You will execute downstream purification steps and collaborate with QA/QC, Facilities & Engineering, PPIC, and Regulatory teams to ensure readiness and continuous improvement.

This role involves rotating 12-hour shifts during startup transitioning to steady-state manufacturing, and may require overtime to meet production schedules.