Cmc Lead (ig And Inframarginals)

CSL BEHRING

Melbourne, Australia
Cmc strategy development
Manufacturing operations oversight
Regulatory submission support
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.
  • Drive alignment and continuous improvement of CMC and QbD best practices across programs.

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

  • CMC strategy development
  • Manufacturing operations oversight
  • Regulatory submission support
  • Biological manufacturing processes
  • QbD documentation
  • Cross-functional team leadership

Nice-to-have

  • Life-changing therapies
  • Collaborative science-led culture
  • Patient-focused innovation

Key Requirements

  • Bachelor's degree in science/engineering
  • 10+ years pharmaceutical industry experience
  • Advanced degree preferred
  • Experience with Ig, plasma-derived, or biotech products
  • Experience supporting regulatory submissions
  • Experience leading global, cross-site project teams

Work Rights

Not specified

Tailored Resume

Cover Letter