Cmc Lead (vaccines)

cslbehring.de

Lead cmc project teams
Define and deliver control strategies
Author and review cmc regulatory submissions
This role is responsible for leading project-specific Chemistry, Manufacturing and Control (CMC) matrix teams

Job Summary

  • This role is responsible for leading project-specific Chemistry, Manufacturing and Control (CMC) matrix teams.
  • The primary responsibility and accountability of the role is to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management (LCM).
  • CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.

Matching Summary

This role is responsible for leading project-specific Chemistry, Manufacturing and Control (CMC) matrix teams.

Skills & Requirements

Must-have

  • Lead CMC project teams
  • Define and deliver control strategies
  • Author and review CMC 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

Key Requirements

  • 10+ years pharmaceutical industry experience
  • Advanced knowledge of biological manufacturing
  • Technical and regulatory writing experience
  • Track records in leading teams

Work Rights

Not specified

Tailored Resume

Cover Letter