amy andriano

Research included applying Self-Assembling Monolayers (SAM) to Au-coated chips for toxin detection

* Developed Macros in Microsoft Excelto collect, analyze, and send out a report regarding production and process data * Data collected and analyzed 22 times faster than previous process * Worked with engineers and technicians to improve effectiveness * Created Aspen HYSYS simulation of manufacturing process * Participated in a process hazard analysis (PHA) review of new reactor unit * United Way Captain of the production unit

* Found the specificities of 4 different PH domain binding proteins in A. thaliana * Applied techniques of cell transformation, protein purification, plant transformation & immunolocalization in research

* FDA approvals:an original Investigational Device Exemption (IDE), IDE Amendments, IDE * Supplements, a 30-Day Notice * Additional experience: Annual Reports, Premarket Approval (PMA) Amendments, PMA/IDE Labeling, * Real-Time Supplements * Manage an IDE for an ongoing clinical study * Lead regulatory strategy discussions with clinical, clinical operations, and statistical teams * Collaborate with various clinical functions to achieve approval without impacting timeline * Develop regulatory strategy to facilitate quick FDA approval * Managing FDA submissions required for IDE upkeep * Manage manufacturing changes for an FDA approved PMA * Developed a more transparent method for assessing and communicating changes * Assess regulatory pathway of all manufacturing changes * Collaborate with the product manufacturing site in Pringy, France to improve communication and * better understand manufacturing processes and the impact of manufacturing changes * Fostered an open relationship with the Pringy Team increasing the quality of communication

* Analyzed and prepared histological samples * Designed, built and maintained study environments

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