Assoc. Director, Drug Substance Commercialisation

539

Ballydine, Co. Tipperary, Ireland
Hybrid
Process chemistry and chemical engineering degree
Cgmp and glp compliance knowledge
Api process scale-up and validation
This role leads technical support for the introduction and production of clinical and commercial active pharmaceutical ingredients at the Ballydine site

Job Summary

  • This role leads 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 continuous improvements to ensure safe and compliant manufacturing.
  • The position requires strong leadership skills to coach team members while managing complex projects involving regulatory compliance and cross-site technology transfers.

Matching Summary

This role leads 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 Chemical Engineering Degree
  • cGMP and GLP Compliance Knowledge
  • API Process Scale-up and Validation
  • Deviation Investigation and Resolution
  • Team Leadership and Performance Management

Nice-to-have

  • Lean Leadership Experience
  • Cross-Functional Collaboration Skills
  • Strategic Thinking and Planning
  • Innovative Problem Solving Approach
  • Budget Oversight and Financial Management

Key Requirements

  • BSc/BEng in Chemistry or Chemical Engineering
  • Experience with electronic batch records and DeltaV systems
  • Knowledge of CMC considerations and new product development

Work Rights

Not specified

Tailored Resume

Cover Letter