Downstream Drug Substance Senior Associate - Flexible

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Amgen North Carolina seeks a Senior Associate Manufacturing - Bulk Drug Substance Downstream to support the facility startup and expansion. You will be hands-on with downstream purification operations including column chromatography, TFF, viral filtration, and activation, ensuring operational readiness and technology transfer.

The role requires coordination across QA/QC, Facilities & Engineering, and production functions, with shifts to support 24/7 manufacturing and startup activities.

Qualifications

• Experience in biotechnology or pharmaceutical plant startups and cGMP environments.
• Knowledge of downstream purification operations and related instrumentation.
• Excellent verbal and written communication (technical) skills.

Responsibilities

• Perform hands-on downstream purification operations and process support.
• Assist in readiness activities for facility expansion and startup.
• Support commissioning, qualification, and startup activities per training.
• Provide operational feedback for safe, compliant manufacturing and continuous improvement.
• Collaborate cross-functionally to ensure equipment, procedures, and workflows are ready.

Skills

column chromatography

TFF

viral filtration

viral inactivation

conjugation

operation readiness

Education

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience

Associates Degree + 2 years manufacturing and/or other regulated environment experience

Bachelors Degree + 6 months manufacturing and/or other regulated environment experience

Master's Degree

Tools

DeltaV

MES

Electronic Batch Records (EBR)

Job description

Amgen North Carolina seeks a Senior Associate Manufacturing - Bulk Drug Substance Downstream to support the facility startup and expansion. You will be hands-on with downstream purification operations including column chromatography, TFF, viral filtration, and activation, ensuring operational readiness and technology transfer.

The role requires coordination across QA/QC, Facilities & Engineering, and production functions, with shifts to support 24/7 manufacturing and startup activities.