Senior Associate Manufacturing - Bulk Drug Substance Upstream

About the role

Amgen is hiring a Senior Associate Manufacturing for its bulk drug substance upstream operations at Amgen North Carolina (ANC), supporting the facility expansion program and facility startup. The role sits in a team responsible for cell culture operations (seed train, SUBs, perfusion, RTF, stainless steel BRXs, depth filtration and centrifugation) and partners across functions to deliver 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 accordance with cGMP procedures (SOPs, MPs, JHAs, CFR) with strict safety and compliance, and initiate quality observations and investigations
• Support operational readiness, equipment preparation, procedure execution, process walkthroughs and commissioning, qualification and startup
• Perform hands-on operations: set-up, cleaning, sanitization, equipment monitoring, in-process sampling, analytical equipment and electronic batch records
• Review documentation (equipment logs, EBRs, ESPs), participate in CAPA programs and drive safety
• Draft and revise SOPs, technical reports and MPs, and advise management on scheduling and process concerns

Required profile

• High school diploma/GED plus 4 years of manufacturing or regulated environment experience, or an associate's degree plus 2 years, or a bachelor's degree plus 6 months, or a master's degree
• Ability to work assigned 12-hour shifts, including during bad weather, some holidays and requested overtime, and to attend non-standard shifts during startup and commissioning
• Preferred: completion of the NC BioWork certificate program, biotech/pharma plant startup experience, cGMP knowledge and basic upstream process knowledge

Required skills

• Technical verbal and written communication
• Microsoft Office proficiency
• Preferred: EBR/MES, Delta V and electronic quality systems

What we offer

• Salary range of $86,048 to $116,418
• Total rewards plans aligned with local industry standards