Cmc Lead - Recombinant

CSL SEQIRUS

Melbourne, Australia
Recombinant protein technology
Biological manufacturing processes
Process design and validation
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
  • Process design and validation
  • Regulatory submissions
  • Quality by Design (QbD)

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter