Ensure compliance and relevance of analytical methods (IPC, DS, and DP) and associated Quality Systems
Responsible for overseeing and managing development as well as analytical routine activities at CLO/CMO; incl. release testing and stability studies
Support in the design of stability study programs, assessing shelf life
Responsible for continuous method verification, including analysis of trend data
Lead analytical transfer workstreams for drug substance and drug product transfers
Support the development, refinement, and implementation of the product control strategy
Oversee the establishment and maintenance of reference materials and responsibility for product-specific method standards
Write and review applicable sections in registration files, variations, and market expansion

University education in Analytical Sciences or equivalent
+5-10 years of progressive experience in analytical development, method validation, and QC/QA interactions for small‑molecule, non‑sterile drug products
Recognized expert in analytical methods for small molecules (HPLC, UPLC, GC, dissolution, residual solvents, impurities profiling, forced degradation, etc.)
Demonstrated experience overseeing analytical activities at CLOs/CMOs, including release and stability testing, troubleshooting, investigations, and analytical method life cycle management
Fluent in English, intermediate to full proficiency in Chinese is a plus
Background in Drug Product manufacturing in oral dose a plus, with experience in hard gelatin capsules highly preferred

Technical Lead

About this role