Exec. Dir., Operations

Newyorkbioconnect

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
  • Manufacturing capacity planning
  • Quality Risk Management

Nice-to-have

  • Innovative and data-driven leadership
  • Continuous improvement mindset
  • Strong communication and decision-making skills
  • Digital and technical mindset
  • Ability to influence across organizational layers
  • Experience with Six Sigma
  • Building diverse talent

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 engaging with regulatory agencies and inspections
  • Proven project management capabilities
  • Knowledge of GMP and global health authority regulations

Work Rights

Not specified

Tailored Resume

Cover Letter