Senior Associate, Bulk Drug Substance Manufacturing Startup

BioSpace; Holly Springs (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Amgen in North Carolina is seeking a Senior Associate in Bulk Drug Substance Manufacturing Services (Days). You will support the ANC2 facility startup, oversee weigh/dispense, material handling, and preparation of media, buffers, and solutions.

The role includes training staff and ensuring safe, compliant operations. During startup, you will collaborate with QA/QC, Facilities & Engineering, PPIC, and Regulatory teams, advancing operational readiness and continuous improvement as the facility

Qualifications

• Experience working in cGMP manufacturing environments.
• Ability to support startup, qualification, and commissioning activities.
• Strong collaboration with QA/QC, E&F, PPIC and regulatory teams.

Responsibilities

• Support services operations including weigh/dispense of raw materials and handling of materials.
• Assist with media, buffer, and solution preparation and component prep activities.
• Coordinate daily activities, train staff, and promote safe, compliant execution.
• Assist in equipment startup, calibration, and qualification tasks during startup.
• Contribute to continuous improvement and CAPA programs.

Skills

Weigh & dispense

Material handling

Media prep

Buffer prep

Solution prep

Autoclave ops

Equipment setup

Process improvement

Staff training

cGMP compliance

Job description

Amgen in North Carolina is seeking a Senior Associate in Bulk Drug Substance Manufacturing Services (Days). You will support the ANC2 facility startup, oversee weigh/dispense, material handling, and preparation of media, buffers, and solutions.

The role includes training staff and ensuring safe, compliant operations. During startup, you will collaborate with QA/QC, Facilities & Engineering, PPIC, and Regulatory teams, advancing operational readiness and continuous improvement as the facility