Cmc Lead - Recombinant

CSL BEHRING

Melbourne, Australia
Lead cmc matrix teams
Define and execute manufacturing strategies
Phase-appropriate control strategies
Lead CMC matrix teams across assigned programs, ensuring delivery of process, analytical, and manufacturing plans aligned to development milestones

Job Summary

  • Lead CMC matrix teams across assigned programs, ensuring delivery of process, analytical, and manufacturing plans aligned to development milestones.
  • Author, review, and support CMC sections of regulatory submissions across development, market authorisation, and lifecycle management.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.

Matching Summary

Lead CMC matrix teams across assigned programs, ensuring delivery of process, analytical, and manufacturing plans aligned to development milestones.

Skills & Requirements

Must-have

  • Lead CMC matrix teams
  • Define and execute manufacturing strategies
  • Phase-appropriate control strategies
  • Author, review, and support regulatory submissions
  • End-to-end oversight of manufacturing delivery
  • Accountable for quality-related CMC deliverables

Nice-to-have

  • Strategic focus and clear communication
  • Drive alignment and continuous improvement
  • Collaborative, science-led culture
  • Inclusion and Belonging at the core

Key Requirements

  • Bachelor's degree in relevant scientific or engineering discipline
  • 10+ years' experience in pharmaceutical industry
  • Strong knowledge of biological manufacturing processes
  • Proven experience supporting regulatory submissions
  • Demonstrated ability to lead by influence

Work Rights

Not specified

Tailored Resume

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