At Noramco, I serve as an analytical and regulatory subject matter expert for commercial small molecule APIs. I author and review CTD Module 3 drug substance content and maintain API Technical Packages that customers reference in NDA and ANDA submissions.
At Purisys, I led phase-appropriate analytical control strategies for Nabilone and Dronabinol from IND-enabling development through commercial launch. I developed and validated more than 20 analytical methods and directed outsourced analytical work with contract laboratories and CROs.
I helped establish Purisys's first dedicated QC laboratory, including instrument selection, installation, qualification, and SOPs. I also owned the qualification and maintenance program for analytical instruments and mentored junior scientists.
Earlier, at Johnson & Johnson, I developed an NIR rapid-release method that reduced bulk ethanol analysis from six hours to under one hour. At the CDC, I developed and validated GLP bioanalytical LC-MS/MS methods for trace antibiotic residues in human blood, serum, and urine.
