Upstream Bulk Drug Substance Manufacturing Senior Associate

BioSpace; Holly Springs (NC); On-site; USD 75,000 - 110,000; Full time

Job summary

Amgen North Carolina is seeking a Senior Associate for Bulk Drug Substance Upstream (Days) to support the expansion and startup of a new facility. You will assist with seed trains, SUBs, perfusion, RTF, and centrifugation, coordinating across QA/QC, Facilities, PPIC, and Regulatory to enable smooth technology transfer and ramp‑up.

During startup, you may work nonstandard shifts; as operations move to steady state, focus will shift to routine manufacturing and continuous improvement with emphasis

Qualifications

• High School Diploma/GED with 4+ years in manufacturing or regulated environment.
• Associates Degree with 2+ years in manufacturing or regulated environment.
• Bachelors Degree with 6 months in manufacturing or regulated environment.
• Master's Degree in a related field.
• Completion of NC BioWork Certificate Program.
• Experience in biotechnology or pharmaceutical plant start up.
• Knowledge of cGMP manufacturing facilities and regulatory expectations.
• Understanding Upstream operation concepts (Vial Thaw, Inoculation, Bioreactors, etc.).
• Excellent verbal and written communication skills.
• Proficient Microsoft Office; knowledge of DeltaV, MES/EBR, and Electronic Quality Systems.

Responsibilities

• Support facility expansion startup and readiness activities.
• Participate in commissioning, qualification and startup tasks as trained.
• Provide operational feedback to ensure safe, compliant, and efficient manufacturing.
• Run hands‑on operations, monitor critical tasks, and complete process documentation.
• Collaborate across QA/QC, Facilities & Engineering, PPIC, Process Development and Regulatory.

Skills

Communication skills

Team collaboration

Education

High School Diploma/GED

Associates Degree

Bachelors Degree

Master's Degree

Tools

DeltaV

MES/EBR

Electronic Quality Systems

Job description

Amgen North Carolina is seeking a Senior Associate for Bulk Drug Substance Upstream (Days) to support the expansion and startup of a new facility. You will assist with seed trains, SUBs, perfusion, RTF, and centrifugation, coordinating across QA/QC, Facilities, PPIC, and Regulatory to enable smooth technology transfer and ramp‑up.

During startup, you may work nonstandard shifts; as operations move to steady state, focus will shift to routine manufacturing and continuous improvement with emphasis