Cmc Lead - Recombinant

CSL

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

Nice-to-have

  • Life-changing therapies
  • Collaborative, science-led culture
  • Global scale and expertise

Key Requirements

  • Bachelor's degree in science/engineering
  • 10+ years pharmaceutical experience
  • Advanced degree strongly preferred
  • Biological manufacturing knowledge
  • Regulatory submission experience

Work Rights

Not specified

Tailored Resume

Cover Letter