- Leveraged scientific, technical and interpersonal skills to bridge the agency’s scientific staff and Deloitte’s technical team for a $4 million new application. Closely worked with the client’s scientific staff on their business needs and authored system requirements based on these business needs for the development team. The application directly supported FDA’s mission by aiding regulatory officials in data inspections globally, generating analytical reports, and determining the veracity of submitted generic drug data while reducing costs, enhancing efficiency and process accuracy.- Designed and refined application mockups after leading recurring exploration deep-dives with internal and external stakeholders to ensure alignment with the problem statement.- Led User Acceptance Trainings and drafted all release materials for 4 successful application releases. Collaborated with Training Lead to instruct several end user trainings for 34 FDA officials. Garnered excitement and support for the product’s current implementation and future enhancements.- Supported Deloitte’s Development and Testing Teams throughout the agile development life cycle of the new application. Utilized Jira boards to create, update, and assign tickets to each sprint.- Identified use cases for the application to eliminate additional bottlenecks. Designed mockups to initiate conversations and gain buy-in from the clients on the increased scope.

- Project 1: Analyzed assay data and authored technical assessment for modifications made to remedy a building's protein fractionation process in which impurities and flaws were identified in a downstream product- Project 2: Created characterization baselines for two buildings to analyze fractionation intermediates. Conducted paste resuspensions under GMP standards and submitted samples to the bioanalytical team to perform specific assays- Additional projects: Performed Bradford assay, created digitized records of samples for location and retrieval, measured conductivity, pH, turbidity, and density of ethanol and resuspension buffer of a fraction previously unused for a new drug

• Developed an automatic quantification algorithm for determining fluorescence distribution in yeast cells to model protein traffic, investigate cell response to therapeutics, and analyze cell morphology defects induced by gene deregulation• Transformed yeast cells, imaged and analyzed the resulting data to investigate the function of epsin (membrane protein)

• Conducted a comprehensive research of mass balance and drug recovery for FDA-approved therapies over the last five years • Summarized and interpreted explanations given for low recoveries of approved drugs to help determine whether further development work would be needed for a drug ready for FDA submission The effort was recognized by the clinical pharmacology team as providing valuable insights for planning and designing additional clinical studies for Purdue Pharma’s drug ready for FDA submission.