Assoc. Director, Drug Substance Commercialisation

medhunter.de

Ballydine, County Tipperary, Ireland
Hybrid
Process chemistry and engineering principles
Cgmp and glp regulatory compliance
Process development and scale-up expertise
The successful candidate will lead process development and scale-up activities to ensure safe, compliant, and efficient production of clinical and commercial APIs

Job Summary

  • The successful candidate will lead process development and scale-up activities to ensure safe, compliant, and efficient production of clinical and commercial APIs.
  • This role combines hands-on technical leadership with people and project management responsibilities within the primary commercialisation facility in Ballydine, Co. Tipperary.
  • The company strives to find solutions for challenging healthcare needs by bringing talented people together in an inclusive environment to drive breakthrough innovation.

Matching Summary

The successful candidate will lead process development and scale-up activities to ensure safe, compliant, and efficient production of clinical and commercial APIs.

Skills & Requirements

Must-have

  • Process chemistry and engineering principles
  • cGMP and GLP regulatory compliance
  • Process development and scale-up expertise
  • Equipment and cleaning validation knowledge
  • Deviation management and investigation skills
  • Electronic batch records and control systems

Nice-to-have

  • Lean leadership and continuous improvement
  • Strategic thinking and cross-functional collaboration
  • Innovative problem-solving capabilities
  • Budget oversight and financial management
  • Strong coaching and team development skills

Key Requirements

  • Degree (BSc/BEng) in Chemistry or Chemical Engineering
  • Experience with process equipment and cleaning validation
  • Knowledge of cGMPs and production operations

Work Rights

Not specified

Tailored Resume

Cover Letter