Cmc Lead

Lilly

Shanghai, China
Cmc strategy and technical oversight
China regulatory landscape navigation
Cross-functional project team collaboration
Lilly ExploR&D partners with biotechs from discovery through clinical proof-of-concept, providing industry-leading capabilities to transform bold science into life-changing medicines

Job Summary

  • Lilly ExploR&D partners with biotechs from discovery through clinical proof-of-concept, providing industry-leading capabilities to transform bold science into life-changing medicines.
  • The Director/Sr. Director - China ExploR&D CMC will oversee CMC activities supporting clinical development programs in China, serving as the primary CMC point of contact.
  • This role requires a strategic leader with deep technical expertise to navigate China's evolving regulatory landscape while maintaining alignment with global CMC strategies and quality standards.

Matching Summary

Lilly ExploR&D partners with biotechs from discovery through clinical proof-of-concept, providing industry-leading capabilities to transform bold science into life-changing medicines.

Skills & Requirements

Must-have

  • CMC strategy and technical oversight
  • China regulatory landscape navigation
  • Cross-functional project team collaboration
  • External partner (CDMO) management
  • Risk identification and mitigation

Nice-to-have

  • Experience with advanced modalities
  • AI/ML tools in CMC development
  • Agility in fast-paced environments
  • Working with emerging companies

Key Requirements

  • PhD in chemistry, chemical engineering, biochemistry, pharmaceutical sciences or related discipline
  • 8+ years of CMC development experience
  • Knowledge of China regulatory requirements (CTA, NMPA)
  • Strong knowledge of ICH guidelines
  • Fluency in Mandarin Chinese (spoken and written)
  • Professional proficiency in English

Work Rights

Not specified

Tailored Resume

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