Greater Boston
Skilled scientist with an engineering background and six years of experience in an FDA regulated industry. In that time, I have demonstrated expertise in process scale-up, process improvement, assay development, and working cross functionally to validate manufacturing equipment and processes through factory acceptance testing and IQ, OQ, and PQ. Additionally, I have an established track record of independently designing experiments to achieve project goals ahead of schedule, driving manufacturing change controls, and generating highly reproducible datasets.
- Key contributor in scaling manufacturing of the COVID-19 vaccine to large scale operation - Aided in technology transfer activities, factory acceptance testing of new equipment, IQ/OQ/PQ, and training of new operators during rapid departmental expansion - Executed sterile and non-sterile manufacturing operations in accordance with cGMP and FDA standards - Authored and reviewed standard operating procedures (SOPs) for the COVID-19 vaccine manufacturing process - Served as a qualified trainer and team captain during COVID-19 vaccine scale up