I develop and validate analytical methods across chromatographic and spectroscopic techniques, and manage the transfer process so results stay consistent from site to site.
I have developed, validated, published, and transferred more than 60 stability-indicating HPLC, GC, and other methods from scratch following ICH guidelines, and authored more than 200 analytical methods, validation and transfer protocols, SOPs, stability protocols, and technical reports.
Across fifteen years in Analytical R&D I developed and validated 18 early-phase and 9 late-phase analytical methods, authored the CM&C sections of IND, CTX, and NDA submissions, and led method transfers to Lilly sites globally, including Brazil, Germany, France, Belgium, and Mexico.
I designed experiments to answer FDA concerns about existing HPLC methods and remediated them, transferred numerous HPLC methods to UPLC and trained others, and developed a stability-indicating method for 12 vitamins in a complex lyophilized multivitamin formulation, drafting the methods and validation protocols and executing the validation.
For large-molecule biologics, I worked with R&D scientists to develop, validate, and transfer HPLC, bioassay, ELISA, SDS-PAGE, capillary electrophoresis (iCE3), and A280 protein methods into the quality control laboratory.
Methods that produce reliable, defensible data — wherever they're run.