Associate Manufacturing: Bulk Drug Substance Upstream

BioSpace; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Benefits package

Bonus program

Stock-based incentives

Time-off plans

Flexible work models

Job summary

Amgen North Carolina (ANC) seeks an Associate Manufacturing for Bulk Drug Substance Upstream - Days. You will support the facility expansion, startup, and ongoing manufacturing operations in a cGMP environment, including seed train, SUBs, perfusion, and downstream processing.

The role requires readiness to work a dynamic schedule, including 12-hour shifts during steady-state, with a focus on readiness, training, and first-time manufacturing execution. Amgen offers strong development and benefits.

Qualifications

• High School/GED with 2+ years manufacturing or regulated environment experience.
• Associates Degree + 6 months manufacturing and/or regulated environment experience.
• Bachelor's Degree.

Responsibilities

• Execute work in accordance with cGMP procedures and policies.
• Support operational readiness and facility startup activities as part of the expansion program and commissioning.
• Perform hands-on manufacturing operations including setup, operation, monitoring, cleaning, and sanitization of equipment and areas.
• Complete washroom activities for equipment; collect in-process samples and complete EBRs.
• Identify and escalate operational issues impacting safety, quality, or schedule.

Skills

Verbal communication

Written communication

Teamwork

Willingness to learn

Problem solving

Education

High School or GED

Associate's degree

Bachelor's degree

Tools

EBR/MES

DeltaV

Electronic quality systems

Job description

Amgen North Carolina (ANC) seeks an Associate Manufacturing for Bulk Drug Substance Upstream - Days. You will support the facility expansion, startup, and ongoing manufacturing operations in a cGMP environment, including seed train, SUBs, perfusion, and downstream processing.

The role requires readiness to work a dynamic schedule, including 12-hour shifts during steady-state, with a focus on readiness, training, and first-time manufacturing execution. Amgen offers strong development and benefits.