Director, Drug Substance Commercialisation & Development

539

Ballydine, Tipperary, Ireland
Hybrid
15+ years process chemistry experience
Api commercial manufacture expertise
Cgmp manufacturing operations knowledge
A leading pharmaceutical company is seeking a Director of Drug Substance Commercialisation & Development in Ballydine, Ireland. This role requires strategic leadership in the commercialization of active pharmaceutical ingredients (APIs) with an emphasis on process development, regulatory compliance, and team management

Job Summary

  • The Director 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 successful candidate must lead a team of technical specialists while ensuring safe, compliant, and robust supply aligned with enterprise objectives.

Matching Summary

Match Score: 85

A leading pharmaceutical company is seeking a Director of Drug Substance Commercialisation & Development in Ballydine, Ireland. This role requires strategic leadership in the commercialization of active pharmaceutical ingredients (APIs) with an emphasis on process development, regulatory compliance, and team management.

Skills & Requirements

Must-have

  • 15+ years process chemistry experience
  • API commercial manufacture expertise
  • cGMP manufacturing operations knowledge
  • Process development and scale up skills
  • Deviation management and inspection readiness

Nice-to-have

  • Strategic thinking and cross-functional leadership
  • Continuous improvement and lean mindset
  • Innovation in alternative approaches
  • Strong executive communication skills
  • Financial management and budgeting capability

Key Requirements

  • Degree (BSc/BEng/Masters/PhD) in Chemistry or Chemical Engineering
  • Minimum 15 years experience in process chemistry and API commercial manufacture
  • Experience with electronic batch records and DeltaV control systems

Work Rights

Not specified

Tailored Resume

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