Associate Manufacturing - Bulk Drug Substance Downstream - Days

Amgen; Holly Springs (NC); On-site; USD 60,000 - 95,000; Full time

Job summary

Amgen in North Carolina is seeking an Associate in manufacturing to support downstream drug substance operations at a new flexible, tech-enabled facility. You will help startup, ensure operational readiness and run routine biologics production, with 12-hour shifts in a 24/7 manufacturing environment.

You will perform cGMP-compliant downstream steps, participate in commissioning and qualification activities, and contribute to safety, quality and compliance within a fast-paced biotech setting.

Qualifications

• High School diploma + 2 years regulated manufacturing experience, or Associate’s Degree + 6 months, or Bachelor's Degree.
• NC BioWorks Certification preferred.
• Biotech/pharma industry experience with familiarity of cGMP and electronic systems (EBR/MES).

Responsibilities

• Execute cGMP-compliant downstream processes—column packing, chromatography, TFF, viral filtration, and final fill—plus equipment setup, operation, monitoring and cleaning.
• Support plant startup, operational readiness and routine production of biologics.
• Participate in commissioning, qualification, troubleshooting and continuous improvement with focus on safety, quality and compliance.

Skills

NC BioWorks Certification

biotech/pharma industry experience

cGMP familiarity

EBR/MES experience

biologics process operations

manufacturing systems

Education

Bachelor's degree

Associate degree

High School diploma

Job description

Role: Associate in manufacturing supporting downstream drug substance operations at Amgen's new flexible, tech-enabled facility. Objectives include supporting plant startup, operational readiness, and routine production of biologics.

Responsibilities encompass executing cGMP-compliant downstream processes—column packing, chromatography, TFF, viral filtration, and final fill—along with equipment setup, operation, monitoring, and cleaning. The role involves participation in commissioning, qualification, troubleshooting, and continuous improvement activities, with a focus on safety, quality, and compliance. Work schedules include early-phase startup hours and 12-hour shift rotations supporting 24/7 manufacturing.

• Requirements: High School diploma + 2 years regulated manufacturing experience, or Associate’s Degree + 6 months, or Bachelor's Degree.

• Preferred skills include completion of NC BioWorks Certification, biotech/pharma industry experience, familiarity with cGMP, and proficiency with electronic systems like EBR/MES. Experience in biologics, process operations, or manufacturing systems is valued.

• Location: North Carolina; shift schedule may include non-standard hours and overtime to support manufacturing operations.