Cmc Lead (vaccines)

cslbehring.ch

Lead cmc project teams
Define control strategies
Author and review regulatory submissions
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)

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.
  • 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

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).

Skills & Requirements

Must-have

  • Lead CMC project teams
  • Define control strategies
  • Author and review regulatory submissions
  • Deliver Quality Section
  • Maintain manufacturing line-of-sight
  • Communicate CMC strategies

Nice-to-have

  • Proactive, solution-oriented approach
  • Continuous improvement on best practices
  • Inclusion and Belonging culture

Key Requirements

  • 10+ years pharmaceutical industry experience
  • Project management and/or leadership by influence experience
  • Advanced knowledge of biological manufacturing processes
  • Technical and regulatory writing experience
  • Track records in leading teams

Work Rights

Not specified

Tailored Resume

Cover Letter