Associate Biotech Manufacturing - Startup & Remote Ops

Amgen; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Remote work options

Competitive benefits

Job summary

Amgen North Carolina (ANC) is hiring an Associate Manufacturing for Bulk Drug Substance Upstream to support the facility expansion and startup. You will enable readiness across seed train, SUBs, perfusion, and related processes while partnering with cross-functional teams to ensure smooth technology transfer and ramp-up for manufacturing operations.

The role requires flexibility for non-standard shifts during startup and transition to steady-state operations, with focus on safety, quality, and

Qualifications

• High School/GED + 2 years manufacturing and/or other regulated environment experience.
• Associate’s Degree + 6 months manufacturing and/or other regulated environment experience.
• Bachelor’s Degree.
• Completion of NC BioWork / BioWorks Certification Program (preferred).
• Experience in a regulated industry such as biotechnology or pharmaceutical manufacturing (preferred).
• Basic understanding of cGMP manufacturing environments (preferred).
• Familiarity with EBR/MES, DeltaV, and electronic quality systems (preferred).
• Strong verbal and written communication skills (preferred).
• Demonstrated desire to learn, grow, and develop manufacturing skills (preferred).
• Ability to work effectively in a team-based manufacturing environment (preferred).

Responsibilities

• Support the facility expansion program and facility startup.
• Participate in training, equipment familiarization, and procedure execution to enable startup.
• Execute readiness tasks supporting commissioning, qualification, and early manufacturing operations.
• Follow defined workflows and procedures to support safe and compliant startup activities.
• Provide operational feedback and elevate issues observed during startup execution.
• Perform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and areas.
• Run and monitor critical process tasks per approved procedures.
• Perform in-process sampling, operate analytical equipment, and complete Electronic Batch Records (EBRs).
• Complete washroom activities for manufacturing equipment.
• Identify and elevate operational issues impacting safety, quality, or schedule.

Skills

Verbal communication

Written communication

Teamwork

Learning mindset

Education

Bachelor's Degree

Associate's Degree

High School/GED

Tools

EBR/MES

DeltaV

Electronic quality systems

Job description

Amgen North Carolina (ANC) is hiring an Associate Manufacturing for Bulk Drug Substance Upstream to support the facility expansion and startup. You will enable readiness across seed train, SUBs, perfusion, and related processes while partnering with cross-functional teams to ensure smooth technology transfer and ramp-up for manufacturing operations.

The role requires flexibility for non-standard shifts during startup and transition to steady-state operations, with focus on safety, quality, and