Cmc Lead (ig And Inframarginals)

CSL SEQIRUS

Melbourne, Australia
Cmc strategy and execution
Biological manufacturing processes
Regulatory submissions 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 and execution
  • Biological manufacturing processes
  • Regulatory submissions support
  • Quality by Design (QbD)
  • Process and analytical development

Nice-to-have

  • Cross-functional leadership
  • Continuous improvement mindset
  • Patient-focused mission

Key Requirements

  • 10+ years pharmaceutical industry experience
  • Bachelor's degree in science/engineering
  • Advanced degree strongly preferred
  • Experience with Ig, plasma-derived, or biotech products
  • Proven regulatory submission support

Work Rights

Not specified

Tailored Resume

Cover Letter