Assoc. Director, Drug Substance Commercialisation

29

Ballydine, Tipperary, Ireland
Hybrid
Process chemistry and engineering principles
Cgmp and glp regulatory compliance
Api manufacturing and validation experience
This role leads the provision of technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients at the Ballydine site

Job Summary

  • This role leads the provision of technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients at the Ballydine site.
  • The successful candidate will oversee process development, scale-up activities, and drive process improvements while ensuring safe, compliant, and efficient production.
  • The position requires strong people management skills to develop team members, delegate appropriately, and provide technical guidance within a collaborative environment.

Matching Summary

This role leads the provision of technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients at the Ballydine site.

Skills & Requirements

Must-have

  • Process chemistry and engineering principles
  • cGMP and GLP regulatory compliance
  • API manufacturing and validation experience
  • Deviation management and investigation
  • Process scale-up and optimization
  • Team leadership and performance coaching

Nice-to-have

  • Lean leadership and continuous improvement
  • Cross-functional collaboration skills
  • Strategic thinking and problem solving
  • Budget oversight and financial management
  • Innovative approach to technical challenges

Key Requirements

  • Degree in Chemistry or Chemical Engineering
  • Experience with process equipment and cleaning validation
  • Knowledge of electronic batch records and control systems

Work Rights

Not specified

Tailored Resume

Cover Letter