Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

Amgen; Holly Springs (NC); On-site; USD 75,000 - 120,000; Full time

Job summary

Amgen is expanding a new biomanufacturing plant and seeking a Senior Associate in Manufacturing (Bulk Drug Substance Upstream) to support startup, commissioning, and ongoing operations.

The role requires experience in cell culture bioprocessing and cross‑functional collaboration to drive process improvements while ensuring GMP compliance across the facility.

Qualifications

• Regulated manufacturing environment experience preferred.
• Biopharma/pharma manufacturing background is a plus.
• Strong collaboration and documentation skills desirable.

Responsibilities

• Oversee cell culture bioprocessing including seed train, SUBs, perfusion, and downstream filtration.
• Ensure operational readiness, execute commissioning, qualification, and startup activities.
• Perform hands‑on equipment setup, monitoring, in-process sampling, and documentation.
• Collaborate cross‑functionally for process improvements and compliance.
• Support qualification, safety, and GMP adherence.

Education

High School diploma

Associate’s degree

Bachelor’s degree

Job description

Role: Senior Associate in Manufacturing (Bulk Drug Substance Upstream) at Amgen, supporting facility expansion, startup, and ongoing operations of a new biomanufacturing plant.

Responsibilities

• oversee cell culture bioprocessing including seed train, SUBs, perfusion, and downstream filtration;
• ensure operational readiness, execute commissioning, qualification, and startup activities;
• perform hands‑on equipment setup, monitoring, in-process sampling, and documentation;
• collaborate cross‑functionally for process improvements and compliance;
• support qualification, safety, and GMP adherence.

Requirements

• High School diploma plus 4 years regulated environment;
• Associate’s degree plus 2 years;
• Bachelor’s degree plus 6 months;
• experience in biopharma or pharmaceutical manufacturing preferred.

High-Value

• biologics
• cell culture
• upstream
• GMP
• cGMP
• process validation
• manufacturing startup
• biotech/pharma regulated environment
• process operation
• equipment handling
• EBR
• electronic systems

Work Setup

• support early startup on standard hours, transition to 12-hour shifts supporting 24/7 manufacturing, including non‑standard hours, holidays, and overtime.