Philadelphia, Pennsylvania, United States
I am a multidisciplinary scientist whose career path has seen me transition from general chemistry though translational pharmacology and applied analytical chemistry in academia to a position in regulatory science at the FDA. During my studies and subsequent research experience, I gained experience in analytical chemistry and synthetic molecular biology, using analytical instruments such as HPLC-MS/GC-MS, GC-QTOF, IR, UV-vis spectrophotometry, flow cytometry, etc. My studies have transitioned from fundamental studies of analytical chemistry in undergrad to more applied studies employing various analytical and molecular techniques to probe the workings of membrane-bound receptors crucial to the functioning of cardiovascular systems in my graduate work. My postdoctoral time was spent in a similar vein, applying LC-MS/MS analysis to human tissue samples and self-maintained Drosophila model organism samples in the field of autism research. My wide-ranging experience at the bench prepared me well for a transition to my current role as a regulatory chemist at the FDA, where I assess the manufacturing processes for pharmaceutical products both pre- and post-approval to ensure that these products are controlled well enough to ensure their safety and efficacy. My areas of expertise in this area include review of sterile dosage forms and control of organic impurities and related substances. This work not only requires assessment of analytical methods and their validations, but also the application of newly acquired knowledge regarding the manufacturing of sterile drugs and the relevant aseptic processing, from a microbiological perspective.
Reviewer of CMC information for drug substances and drug products, with a focus on assessment of analytical methods, review of sterile processing information covering the manufacture of sterile injectable dosage forms, and development of guidance regarding control of impurities in finished dosage forms. Performed risk-based assessment of submissions from industry to determine alignment with established guidance and current best practices for control of drug product manufacturing. Performed in additional roles as an Ascent change manager and facilitator and successfully mentored and trained several new team members.
Graduate student in the lab of Associate Professor Emer Smyth.
Reviewed new and continuing applications for clinical research, carefully weighing the proposed benefit of new research against the need for protection of human subjects engaged by such research efforts.
I carried out an independent research project studying the thermodynamics of high performance liquid chromatography during my time as a student at Ursinus, including a summer working with the Summer Undergraduate Research Fellows Program sponsored by Merck. I earned an honors degree in chemistry for these efforts.
2 years spent as a resident advisor to freshmen students in a large residence hall. 1 year spent as a senior resident advisor, overseeing other RAs while acting as a resident advisor to a number of smaller, lower-occupancy residence halls.