

Results-driven R&D supervisor with extensive experience in the pharmaceutical sector. Successfully led teams through all phases of drug development, from method design to validation for global markets. Specialized in optimizing laboratory workflows while ensuring compliance with GMP/GLP standards and expediting product registration through precise technical documentation and effective cross-functional collaboration.
Supervised calibration and maintenance of high-precision instruments, enhancing reliability of analytical results.
Ensured compliance with JFDA, SFDA, USFDA, and ICH guidelines for regulatory standards.
Led development and validation of analytical methods for finished pharmaceutical products.
Designed and executed dissolution profile comparisons, facilitating regulatory approval for bioequivalence studies.
Optimized HPLC, UPLC, GC, and UV-spectrophotometry for routine and non-routine analyses.
Authored and approved critical documentation including SOPs and validation reports per GMP and GLP standards.
Audited analytical reports and laboratory logbooks, ensuring compliance with data integrity standards.
Supported formulation teams in selecting quality API suppliers to accelerate product registration.