Associate Director, External Manufacturing

Merck & Co., Inc.

Rahway, NJ, USA
Not specified; not specified; not specified
Fully remote
7 years relevant work experience in manufacturing
5 years experience in drug substance manufacturing
Leading new product introduction and technical transfers
Merck & Co., Inc. is seeking an Associate Director, External Manufacturing, to oversee technical operations related to drug substance manufacturing within its External Manufacturing Network. The role requires strong leadership, collaboration with external partners, and expertise in process development and validation

Job Summary

  • This role serves as the primary technical interface between internal operations and external manufacturing partners to ensure commercial success.
  • The team is responsible for executing technical due diligence, managing complex investigations, and driving continuous process verification programs.
  • Candidates must demonstrate strong problem-solving skills and the ability to foster proactive risk management within a collaborative environment.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an Associate Director, External Manufacturing, to oversee technical operations related to drug substance manufacturing within its External Manufacturing Network. The role requires strong leadership, collaboration with external partners, and expertise in process development and validation.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 7 years relevant work experience in manufacturing
  • 5 years experience in drug substance manufacturing
  • Leading new product introduction and technical transfers
  • Process development scale up and robustness
  • Root cause analysis and risk assessment mitigation
  • Strong knowledge of quality systems and validation

Nice-to-have

  • Lean Manufacturing or Six Sigma experience
  • Project management experience
  • Knowledge of flow chemistry and enzyme manufacture
  • Experience supporting regulatory inspections
  • Inclusive people leadership creating safe culture

Key Requirements

  • Bachelor's degree in engineering or chemistry sciences
  • Minimum 7 years of relevant manufacturing experience
  • Minimum 5 years experience in drug substance
  • Valid driving license (implied by travel requirement)
  • English language proficiency required

Work Rights

Not specified

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