Senior Associate Bulk Drug Substance Upstream Startup

Amgen

Holly Springs (NC)

On-site

USD 75,000 - 110,000

Full time

3 days ago

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Job summary

Amgen North Carolina is seeking a Senior Associate in Bulk Drug Substance Upstream to support the facility expansion, startup, and ramp‑up. The role involves seed train and production operations, collaboration with QA/QC, F&E, PPIC, Regulatory, and continuous improvement initiatives.

The position requires adaptability to 8am–5pm initially and a later 12‑hour shift, with overtime as needed to meet startup milestones. Strong cGMP knowledge and safety focus are essential.

Qualifications

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
Associate’s Degree + 2 years manufacturing and/or other regulated environment experience
Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience
Master's Degree in a relevant field (preferred) and strong cGMP knowledge

Responsibilities

Support startup, ramp-up, and transfer activities for ANC facility.
Perform hands-on operations: setup, cleaning, and documentation (EBR).
Collaborate across QA/QC, Facilities & Engineering, PPIC, Regulatory for readiness.
Drive safety and continuous improvement in daily operations.

Skills

Verbal and written communication

Teamwork and collaboration

Safety and compliance mindset

Education

Master's Degree

Bachelor’s Degree

Associate’s Degree

High School Diploma/GED + 4 years manufacturing experience

Tools

DeltaV

MES

Electronic Quality Systems

Job description

The position requires adaptability to 8am–5pm initially and a later 12‑hour shift, with overtime as needed to meet startup milestones. Strong cGMP knowledge and safety focus are essential.

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