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Front Line Manufacturing Manager - Bulk Drug Substance Services - Days

External
Amgen logoAmgen · - North Carolina - Holly Springs
Full-timeRemote6d ago
ComplianceLeadershipSAFe
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Responsibilities

  • 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 day shift supporting 24/7 operations.
  • Win
  • What we expect from you
  • We are all different, yet we all use our unique contributions to serve patients. The biotechnology professional we seek is a manager with these qualifications.

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
  • Bachelor's degree in Life Sciences or Engineering
  • Experience with facility startup, commissioning, or operational readiness
  • Biologics / drug substance manufa

Additional Information

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Front Line Manufacturing Manager - Bulk Drug Substance Services - Days


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