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Amgen Logo Amgen · Manufacturing

Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

United States, Holly Springs Employment contract 106148.00 - 143612.00 USD / Year · Job Posted May 04, 2026
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Job Description

Let’s do this. Let’s change the world. Amgen is seeking a Manager Manufacturing Upstream to provide frontline leadership supporting the facility expansion program and facility startup. This essential role will lead a team responsible for manufacturing cell culture operations including seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation, while partnering across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within the new facility.

Job Responsibility

  • Frontline Leadership: Lead, develop, and coach a manufacturing team
  • set clear performance expectations
  • foster a strong culture of safety, quality, and accountability
  • Facility Startup & Operational Readiness: Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility
  • Manufacturing Operations: Ensure safe, cGMP-compliant execution
  • drive performance across safety, quality, schedule, and cost
  • resolve deviations and operational issues
  • Technology Transfer & Process Implementation: Support transfer and implementation of manufacturing processes
  • ensure manufacturability, troubleshooting, and continuous improvement
  • Cross-Functional Collaboration: Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp-up
  • Compliance & Inspection Readiness: Maintain inspection readiness and adherence to regulatory and Amgen quality standards
  • Continuous Improvement: Identify and drive efficiency, reliability, and scalability improvements as operations mature
  • Shift Support: Work non-standard hours as required, transitioning to a 12-hour 2-2-3 dayshift supporting 24/7 operations

Requirements

  • Doctorate degree OR Master's degree and 3 years of Manufacturing or Operations experience OR Bachelor's degree and 5 years of Manufacturing or Operations experience OR Associate's degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
  • AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Nice to have

  • Bachelor's degree in Life Sciences or Engineering
  • Experience with facility startup, commissioning, or operational readiness
  • Biologics / drug substance manufacturing experience (Upstream)
  • cGMP manufacturing experience (5+ years preferred)
  • Experience with technology transfer and process implementation
  • Prior Area Lead / Specialist / Manager experience
  • Strong leadership, performance management, and conflict-resolution skills
  • Solid understanding of regulatory requirements
  • Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS, and electronic quality systems

What we offer

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
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