Cmc Lead (vaccines)

Centerforintegrationscience

Not specified (potential for hybrid or onsite presence based on project requirements)
Lead cmc project teams
Define and deliver control strategies
Author and review cmc regulatory submissions
The CMC Lead position at CSL Seqirus involves leading project-specific Chemistry, Manufacturing, and Control teams to ensure the definition and delivery of CMC packages throughout clinical development and market authorization. The ideal candidate should have extensive experience in the pharmaceutical industry, particularly in manufacturing operations and project management, alongside strong leadership and regulatory knowledge

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 and is a major contributor to the prevention of influenza globally.

Matching Summary

Match Score: 85

The CMC Lead position at CSL Seqirus involves leading project-specific Chemistry, Manufacturing, and Control teams to ensure the definition and delivery of CMC packages throughout clinical development and market authorization. The ideal candidate should have extensive experience in the pharmaceutical industry, particularly in manufacturing operations and project management, alongside strong leadership and regulatory knowledge.

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 delivery
  • Communicate CMC strategies and progress

Nice-to-have

  • Proactive, solution-oriented approach
  • Strong matrix leadership skills
  • Continuous improvement on best practices
  • Cross-functional leadership

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