Assoc. Director, Drug Substance Commercialisation

med-in.at

Ballydine, Co. Tipperary, Ireland
Hybrid
Process development and scale-up
Gmp and glp compliance
Api manufacturing
The role combines hands-on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production of clinical and commercial APIs

Job Summary

  • The role combines hands-on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production of clinical and commercial APIs.
  • The Ballydine site is the primary commercialisation facility within the network, supporting new process scale-up and transfer to commercial manufacture across internal and external partners.
  • The company values inclusive innovation and strives to find solutions for challenging healthcare needs by bringing talented and committed people together.

Matching Summary

The role combines hands-on technical leadership with people and project management responsibilities to ensure safe, compliant, and efficient production of clinical and commercial APIs.

Skills & Requirements

Must-have

  • Process development and scale-up
  • GMP and GLP compliance
  • API manufacturing
  • Regulatory compliance and audits
  • Process chemistry and engineering
  • Deviation management systems
  • Cross-functional teamwork

Nice-to-have

  • Strategic thinking and project management
  • Lean leadership experience
  • Coaching and team development
  • Financial management and budget awareness
  • Innovative problem solving
  • Environmental and safety policy knowledge

Key Requirements

  • Degree in Chemistry or Chemical Engineering
  • Experience with cGMP production operations
  • Knowledge of electronic batch records systems
  • Experience in process, equipment, and cleaning validation
  • Strong presentation and communication skills
  • Performance and people management experience

Work Rights

Not specified

Tailored Resume

Cover Letter