Oversee Chemistry, Manufacturing, and Controls (CMC) activities supporting clinical development programs in China
Job Summary
Oversee Chemistry, Manufacturing, and Controls (CMC) activities supporting clinical development programs in China.
Serve as the primary CMC point of contact for China-based projects, coordinating with sponsors, ExploR&D China, CDMOs, and regulatory authorities.
Provide CMC strategy, leadership, and technical oversight for drug substance, drug product, and analytical development, ensuring scientific rigor and regulatory compliance.
Matching Summary
Oversee Chemistry, Manufacturing, and Controls (CMC) activities supporting clinical development programs in China.
Skills & Requirements
Must-have
CMC strategy and technical oversight
China regulatory submissions (CTA)
Cross-functional team collaboration
CDMO network building and oversight
Risk management and mitigation strategies
Nice-to-have
AI/ML tools in CMC development
Advanced therapeutic modalities experience
Fast-paced environment adaptability
Pragmatic problem-solving skills
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)