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Front Line Manufacturing Manager (Bulk Drug Substance - Downstream) - Night Shift

Amgen Inc

Amgen seeks a Front Line Manufacturing Manager for night shift operations at its advanced drug substance facility in Holly Springs, North Carolina. This role involves overseeing manufacturing teams on a 12-hour rotating schedule, ensuring GMP compliance, driving continuous improvement, and developing staff while maintaining safe, efficient production operations.

Responsibilities

  • Oversee manufacturing teams on 12-hour night shift rotation producing GMP drug substances
  • Champion safe, compliant production environment and lead continuous improvement initiatives
  • Recruit, train, coach, develop and evaluate staff; ensure adherence to production schedules
  • Collaborate with cross-functional teams on process execution, problem-solving, and CAPA development
  • Ensure regulatory compliance, proper gowning/aseptic techniques, and workplace safety standards

Requirements

  • Previous managerial experience directly managing people or leading teams and projects
  • Bachelor's degree in Life Sciences or Engineering preferred
  • 5+ years process experience in cGMP manufacturing facility preferred
  • 3+ years experience in production Area Lead, Specialist, or Manager role preferred
  • Strong leadership, coaching, mentoring, and team-building skills
  • Understanding of downstream purification operations and cGMP/CFR regulatory compliance
Vacancy posted 6 days ago
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