Cmc Lead (ig And Inframarginals)

CSL

Melbourne, Australia
Cmc matrix team leadership
Manufacturing strategy execution
Regulatory submission support
At CSL, our purpose is to deliver life‑changing therapies to patients worldwide through innovative biotherapeutics

Job Summary

  • At CSL, our purpose is to deliver life‑changing therapies to patients worldwide through innovative biotherapeutics.
  • The CMC Lead role involves leading matrix teams, shaping strategy, and ensuring high-quality CMC packages that support timely development and regulatory success.
  • CSL offers a purpose-driven work environment with global scale, world-leading expertise in immunoglobulins and biological products, and a collaborative, science-led culture.

Matching Summary

At CSL, our purpose is to deliver life‑changing therapies to patients worldwide through innovative biotherapeutics.

Skills & Requirements

Must-have

  • CMC matrix team leadership
  • manufacturing strategy execution
  • regulatory submission support
  • biological manufacturing processes
  • process design and validation
  • quality-related CMC deliverables

Nice-to-have

  • cross-functional collaboration
  • global multi-site project experience
  • strategic focus and problem-solving
  • clear communication style
  • continuous improvement mindset

Key Requirements

  • Bachelor’s degree in scientific or engineering discipline
  • 10+ years pharmaceutical industry experience
  • Experience in manufacturing operations and validation
  • Knowledge of advanced CMC/QbD requirements
  • Proven regulatory submission experience
  • Ability to lead global cross-site teams

Work Rights

Not specified

Tailored Resume

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