Exec. Dir., Operations

microsatsystems.biz

Dunboyne, ,
Biologics drug substance manufacturing
Operational excellence and lean methodologies
Technology transfer leadership
This position will drive transformational change for capacity realization and operational excellence to deliver all components of stable manufacturing teams and processes for a diverse and complex Biologics pipeline

Job Summary

  • This position will drive transformational change for capacity realization and operational excellence to deliver all components of stable manufacturing teams and processes for a diverse and complex Biologics pipeline.
  • Responsible for all Manufacturing Operations within four state of the art multi-product facilities used for clinical and commercial manufacture of Biologics Drug Substance, a Cell Banking facility and associated Weigh/Dispense and Solution Prep activities.
  • Drive a strong compliance mindset within the organisation, including proactive safety and quality culture, and adherence to all regulatory expectations.

Matching Summary

This position will drive transformational change for capacity realization and operational excellence to deliver all components of stable manufacturing teams and processes for a diverse and complex Biologics pipeline.

Skills & Requirements

Must-have

  • Biologics Drug Substance manufacturing
  • Operational Excellence and Lean methodologies
  • Technology transfer leadership
  • Regulatory compliance and inspection readiness
  • Cross-functional team leadership
  • Production scheduling and capacity management

Nice-to-have

  • Innovative thinker with problem-solving skills
  • Strong technical and digital mindset
  • Data-driven decision making
  • Continuous improvement culture
  • Ability to influence across organizational layers
  • Inspirational leadership and coaching

Key Requirements

  • Degree qualification or equivalent in Science, Engineering or Technical field
  • At least 15 years leadership in cross-functional manufacturing environment
  • Demonstrated Biologics manufacturing and technology transfer experience
  • Experience with GMP and global health authority regulations
  • Proven project management capabilities
  • Experience engaging with regulatory agencies

Work Rights

Not specified

Tailored Resume

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