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Director Non-Sterile Operations

Thermo Fisher Scientific

Thermo Fisher Scientific seeks a Director of Non-Sterile Operations to lead manufacturing, packaging, inspection, and device assembly at its Greenville, North Carolina pharmaceutical campus. The role focuses on operational excellence, regulatory compliance, and continuous improvement across non-sterile product lines including oral solids and continuous manufacturing platforms.

Responsibilities

  • Lead non-sterile operations including packaging, inspection, auto-injector assembly, oral solid dose, and continuous manufacturing platforms
  • Drive accountability and measurable results across safety, quality, delivery, cost, and people metrics
  • Ensure sustained cGMP compliance through quality systems, documentation, investigations, and risk management
  • Support technology transfer, scale-up, and commercialization activities across multiple manufacturing programs
  • Develop and foster high-performing teams with culture of engagement and continuous improvement

Requirements

  • Bachelor's degree in Engineering, Operations Management, or related field
  • 10+ years progressive operations leadership in pharmaceutical or biopharmaceutical manufacturing
  • Deep knowledge of cGMP regulations including FDA 21 CFR Parts 210/211, 820, and EU GMP
  • Experience with automated assembly systems, high-speed packaging, continuous manufacturing technologies
  • Strong leadership and financial acumen with cross-functional stakeholder influence
  • Ability to travel up to 25% including international locations
Vacancy posted 5 days ago
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