Senior Specialist, External Manufacturing

Merck & Co., Inc.

Rahway, NJ, USA
Not specified; not specified; not specified
Hybrid
7 years manufacturing experience
Drug substance process development
Technical transfer execution
Merck & Co., Inc. is seeking a Senior Specialist for External Manufacturing, focused on drug substance technical leadership within their External Manufacturing Network. The role demands significant experience in drug substance manufacturing, technical transfers, and collaboration with external partners to ensure operational excellence and compliance

Job Summary

  • The role serves as the primary technical interface between internal operations and external manufacturing partners to ensure commercialization success.
  • Candidates will lead technical due diligence, execute complex technical transfers, and drive continuous process verification programs for small molecule drugs.
  • This position requires strong collaboration across quality, regulatory, and operations teams to foster proactive risk management and innovation within the network.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking a Senior Specialist for External Manufacturing, focused on drug substance technical leadership within their External Manufacturing Network. The role demands significant experience in drug substance manufacturing, technical transfers, and collaboration with external partners to ensure operational excellence and compliance.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 7 years manufacturing experience
  • Drug substance process development
  • Technical transfer execution
  • Process validation strategies
  • Root cause analysis skills
  • External partner management

Nice-to-have

  • Project management experience
  • Regulatory inspection support
  • Lean Six Sigma methodology
  • Continuous improvement mindset
  • Psychologically safe culture
  • Global regulatory knowledge

Key Requirements

  • Bachelor's degree in engineering or chemistry sciences
  • Minimum 7 years relevant work experience
  • Minimum 5 years in drug substance manufacturing
  • Valid driving license required for travel
  • English language proficiency (written and oral)

Work Rights

Not specified

Tailored Resume

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