Cmc Lead - Recombinant

CSL Limited

Recombinant protein technology
Biological manufacturing processes
Cmc strategy
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

  • Recombinant protein technology
  • Biological manufacturing processes
  • CMC strategy
  • Regulatory submissions
  • Process design and validation

Nice-to-have

  • Cross-functional team leadership
  • Strategic focus
  • Continuous improvement
  • Science-led culture

Key Requirements

  • Bachelor's degree in science or engineering
  • 10+ years pharmaceutical industry experience
  • Advanced degree strongly preferred
  • Experience with biological manufacturing processes
  • Experience supporting regulatory submissions

Work Rights

Not specified

Tailored Resume

Cover Letter