Cmc Lead (vaccines)

CSL Seqirus

**
Lead cmc project teams
Define and deliver control strategies
Author and review regulatory submissions
** CSL Seqirus is seeking a CMC Lead for vaccines to lead project-specific Chemistry, Manufacturing, and Control (CMC) teams, ensuring the delivery of CMC packages during clinical development and market authorization. The ideal candidate will have over 10 years of experience in the pharmaceutical industry, particularly in manufacturing operations and CMC principles. **

Job Summary

  • This role is responsible for leading project-specific Chemistry, Manufacturing and Control (CMC) matrix teams, defining and delivering contemporary CMC packages during clinical development, market authorization, and Life Cycle Management (LCM).
  • The CMC Lead defines the manufacturing plan, ensures clinical supply, and provides technical guidance, operational coordination, and cross-functional leadership within Integrated Project Teams (IPTs).
  • CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness, utilizing various technologies to offer a broad portfolio of differentiated influenza vaccines.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking a CMC Lead for vaccines to lead project-specific Chemistry, Manufacturing, and Control (CMC) teams, ensuring the delivery of CMC packages during clinical development and market authorization. The ideal candidate will have over 10 years of experience in the pharmaceutical industry, particularly in manufacturing operations and CMC principles. **

Skills & Requirements

Must-have

  • Lead CMC project teams
  • Define and deliver control strategies
  • Author and review regulatory submissions
  • Accountable for Quality Section delivery
  • Maintain line-of-sight to manufacturing
  • Communicate CMC strategies and progress

Nice-to-have

  • Proactive, solution-oriented approach
  • Strong matrix leadership skills
  • Continuous improvement on best practices
  • Experience working across international teams

Key Requirements

  • 10+ years of pharmaceutical industry experience
  • Bachelor's degree in a scientific or technical field
  • Advanced degree (MS or PhD) strongly preferred
  • Demonstrated project management experience
  • Technical and regulatory writing experience

Work Rights

Not specified

Tailored Resume

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