Director, Drug Substance Commercialisation & Development

Merck & Co., Inc.

Ballydine, Tipperary, Ireland
Hybrid
15+ years in api commercial manufacture
Process development and scale-up expertise
Cgmp manufacturing operations knowledge
Merck & Co., Inc. is seeking a Director of Drug Substance Commercialisation & Development at their Ballydine site in Ireland. The role requires strategic leadership in the development and commercial manufacture of active pharmaceutical ingredients, ensuring compliance and driving continuous improvement

Job Summary

  • The successful candidate will provide strategic and technical leadership for the introduction, development, and commercial manufacture of clinical and commercial active pharmaceutical ingredients.
  • This role carries end-to-end accountability for Drug Substance commercialisation activities including process development, scale up, validation, and lifecycle management at the Ballydine site.
  • The company embraces an inclusive environment where talented people come together to find solutions for some of the world's most challenging healthcare needs.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking a Director of Drug Substance Commercialisation & Development at their Ballydine site in Ireland. The role requires strategic leadership in the development and commercial manufacture of active pharmaceutical ingredients, ensuring compliance and driving continuous improvement.

Skills & Requirements

Must-have

  • 15+ years in API commercial manufacture
  • Process development and scale-up expertise
  • cGMP manufacturing operations knowledge
  • Chemical or Process Engineering degree
  • DevOps electronic batch record systems
  • Deviation management and inspection readiness

Nice-to-have

  • Lean and continuous improvement mindset
  • Cross-functional strategic thinking
  • Innovation in alternative approaches
  • Executive level communication skills
  • Sustainability impact evaluation

Key Requirements

  • Minimum 15 years experience in process chemistry
  • Degree in Chemistry, Pharmacy, or Chemical Engineering
  • Strong background in equipment and cleaning validation
  • Proven capability in financial management and budgeting

Work Rights

Not specified

Tailored Resume

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