At Trident Strategic Solutions, I provide GMP, ISO, and audit support services for the pharmaceutical sector. I also manage global supplier quality audits for APIs and complex manufacturing components.
At eVenus Pharmaceutical Laboratories Inc, I directed regulatory, clinical, quality, and supply chain operations. I prepared and reviewed submissions including INDs, ANDAs, DMFs, ASMFs, and MAAs, and managed bioequivalence clinical programs across U.S., Canadian, and European markets.
Earlier, at JANSSEN PHARMACEUTICAL, I supported regulated non-clinical and clinical development programs, developed and validated bioanalytical methods, and served as Functional Principal Investigator for multi-site programs. My experience also includes analytical method development and validation at Exygen Research and GCMS testing at Analytical Laboratories Services Inc.
