Associate Director, External Manufacturing

Merck & Co., Inc.

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Drug substance manufacturing experience
Technical transfer execution
Process development and scale up
** Merck & Co., Inc. is seeking an Associate Director for External Manufacturing to lead technical operations and support drug substance manufacture through partnerships with external organizations. The role emphasizes technical excellence, collaboration, and innovation within the field of small molecule manufacturing. **

Job Summary

  • This role involves leading technical operations to support drug substance manufacture within an extensive external manufacturing network.
  • The successful candidate will act as the primary interface on technical issues between internal operations and external partners while ensuring adherence to regulatory standards.
  • Key responsibilities include executing technical due diligence, managing complex investigations, and driving continuous process verification programs.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking an Associate Director for External Manufacturing to lead technical operations and support drug substance manufacture through partnerships with external organizations. The role emphasizes technical excellence, collaboration, and innovation within the field of small molecule manufacturing. **

Skills & Requirements

Must-have

  • Drug substance manufacturing experience
  • Technical transfer execution
  • Process development and scale up
  • Validation strategy execution
  • External partner technical leadership

Nice-to-have

  • Flow chemistry knowledge
  • Enzyme manufacture experience
  • Lean Manufacturing or Six Sigma
  • Regulatory inspection support
  • Bio-catalysis background

Key Requirements

  • Bachelor's degree in engineering or chemistry sciences
  • Minimum 7 years relevant work experience in manufacturing
  • Minimum 5 years experience in drug substance
  • Experience leading new product introduction and technical transfers
  • Strong problem-solving and root cause analysis skills

Work Rights

Not specified

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