Cmc Lead

Lilly

Shanghai, China
Cmc technical leadership
China regulatory strategy
Cdmo network management
The Director/Sr. Director - China ExploR&D CMC will oversee Chemistry, Manufacturing, and Controls (CMC) activities supporting clinical development programs in China

Job Summary

  • The Director/Sr. Director - China ExploR&D CMC will oversee Chemistry, Manufacturing, and Controls (CMC) activities supporting clinical development programs in China.
  • This individual will serve as the primary CMC point of contact for China-based projects and will be responsible for ensuring seamless coordination between the sponsor, ExploR&D China team, contract manufacturing organizations (CDMOs), and Chinese regulatory authorities.
  • The ideal candidate brings deep technical expertise spanning drug substance, drug product, and analytical development across multiple therapeutic modalities.

Matching Summary

The Director/Sr. Director - China ExploR&D CMC will oversee Chemistry, Manufacturing, and Controls (CMC) activities supporting clinical development programs in China.

Skills & Requirements

Must-have

  • CMC technical leadership
  • China regulatory strategy
  • CDMO network management
  • Risk management and mitigation
  • Cross-functional collaboration

Nice-to-have

  • AI/ML in CMC
  • Advanced modalities experience
  • Fast-paced environment adaptability
  • Emerging company collaboration

Key Requirements

  • PhD in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or related discipline
  • 8+ years CMC development experience
  • Knowledge of China regulatory requirements
  • Fluency in Mandarin Chinese
  • Professional proficiency in English

Work Rights

Not specified

Tailored Resume

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