Cmc Lead (vaccines)

Seqirus

Holly Springs, NC, United States
Cmc project team leadership
Manufacturing operations expertise
Process design and validation
This role is responsible for leading project-specific Chemistry, Manufacturing and Control (CMC) matrix teams to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management

Job Summary

  • This role is responsible for leading project-specific Chemistry, Manufacturing and Control (CMC) matrix teams to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management.
  • CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness with state-of-the-art production facilities in the U.S., the U.K., and Australia.
  • At CSL, Inclusion and Belonging is at the core of the mission, fueling innovation by celebrating differences and creating a culture of curiosity and empathy.

Matching Summary

This role is responsible for leading project-specific Chemistry, Manufacturing and Control (CMC) matrix teams to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management.

Skills & Requirements

Must-have

  • CMC project team leadership
  • Manufacturing operations expertise
  • Process design and validation
  • Regulatory submission support
  • Cross-functional team coordination
  • Quality Section delivery accountability
  • Matrix leadership and program management

Nice-to-have

  • Advanced knowledge of biological manufacturing
  • Experience with plasma derived therapies
  • International team collaboration
  • Technical and regulatory writing skills
  • Proactive problem-solving approach
  • Strong communication skills
  • Inclusion and belonging culture

Key Requirements

  • Bachelor’s degree in relevant scientific or technical field
  • 10+ years pharmaceutical industry experience
  • Experience in manufacturing operations and process validation
  • Project management or leadership experience
  • Advanced degree preferred
  • Fluent English
  • Track record in leading teams

Work Rights

Not specified

Tailored Resume

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