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Associate Director, Engineering

$142.4k - $224.1k

Merck

Merck seeks an Associate Director of Engineering to lead technical transfers and commercial manufacturing operations with external biologics partners. This role requires deep biologics manufacturing expertise and cross-functional leadership to ensure successful technology transfers, regulatory compliance, and supply chain optimization across multiple therapeutic nodes.

Responsibilities

  • Serve as primary technical liaison between company and external manufacturing partners for technology transfers
  • Oversee technical due diligence, site readiness, and validation strategies for new and existing products
  • Lead cross-functional teams to identify partnership risks, resolve production issues, and optimize processes
  • Review and approve external partner process changes, deviations, and batch record modifications
  • Ensure regulatory compliance, inspection readiness, and alignment across quality, operations, and commercialization functions

Requirements

  • Bachelor's degree in Engineering or applicable Science; advanced degree preferred
  • Minimum 8 years post-bachelor's experience in drug substance/product biologics or vaccines manufacturing
  • Demonstrated expertise leading technical transfers in manufacturing environments
  • Advanced problem-solving and cross-functional team leadership capabilities
  • Strong knowledge of biologics process sciences, analytics, and manufacturing operations
  • Experience with Lean Manufacturing and continuous process improvement preferred
Vacancy posted 10 days ago
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