Associate Manufacturing - Bulk Drug Substance Downstream

About the role

Amgen is hiring an Associate Manufacturing professional for its North Carolina facility, supporting the expansion program and facility startup of the new FleX Batch drug substance manufacturing plant. The role covers downstream purification operations such as column packing, chromatography, TFF, viral filtration, viral inactivation, conjugation and final fill, working with cross-functional partners to ensure operational readiness, technology transfer and ramp-up. Early phases focus on readiness, training and startup; later phases move to routine manufacturing and continuous improvement.

Key responsibilities

• Work in line with cGMP procedures, SOPs, MPs, JHAs and CFRs, following gowning and aseptic techniques, and documenting deviations and quality events
• Support operational readiness, training, equipment familiarization and startup, including commissioning, qualification and early manufacturing
• Perform hands-on manufacturing: setup, operation, monitoring, cleaning and sanitization of equipment and areas
• Run and monitor critical process tasks, perform in-process sampling, operate analytical equipment and complete Electronic Batch Records
• Escalate operational issues affecting safety, quality or schedule and maintain a clean, compliant environment

Required profile

• High school/GED plus 2 years of manufacturing or regulated-environment experience, or an Associate's degree plus 6 months, or a Bachelor's degree
• Preferred: NC BioWorks certification, biotechnology or pharmaceutical experience, and basic cGMP process experience
• Ability to work 12-hour shifts (5:45 am to 6:15 pm) after startup, including weekends, holidays and overtime

Required skills

• Microsoft Office
• Knowledge of EBR/MES, Delta V and electronic quality systems (preferred)
• Strong verbal and written communication and teamwork

What we offer

• Salary range of $70,985 to $96,038 depending on skills, experience and qualifications
• Health, dental and vision coverage, life and disability insurance, retirement savings plan and stock-based incentives
• Annual bonus or sales-based incentives, time-off plans and flexible work models where possible