Assoc. Director, Drug Substance Commercialisation

leHACK

Ballydine, Co. Tipperary, Ireland
Hybrid
Process chemistry and engineering principles
Cgmp and glp regulatory compliance
Api manufacturing and scale-up experience
This role combines hands-on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production of active pharmaceutical ingredients

Job Summary

  • This role combines hands-on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production of active pharmaceutical ingredients.
  • The successful candidate will lead process development and scale-up activities while driving process improvements and resolving significant processing issues at the primary commercialisation facility.
  • The position requires strong technical expertise in CMC considerations and the ability to translate priorities into actionable plans while holding teams accountable for delivery.

Matching Summary

This role combines hands-on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production of active pharmaceutical ingredients.

Skills & Requirements

Must-have

  • Process chemistry and engineering principles
  • cGMP and GLP regulatory compliance
  • API manufacturing and scale-up experience
  • Deviation management and investigation
  • Equipment and cleaning validation

Nice-to-have

  • Strategic thinking and leadership skills
  • Cross-functional team collaboration
  • Lean leadership and process optimization
  • Budget oversight and financial management
  • Innovative problem-solving abilities

Key Requirements

  • Degree (BSc/BEng) in Chemistry or Chemical Engineering
  • Experience with electronic batch records and control systems
  • Knowledge of HR, training, and process safety management

Work Rights

Not specified

Tailored Resume

Cover Letter