Product Manager
CurrentServes as co-PI on grant for development of two products. Write NIH grants for continued funding.Wrote and submitted two Investigational New Drug (IND) applications in the eCTD format to the FDA for first in human clinical trials. Corresponded with the FDA following submissionDeveloped relevant Chemistry, Manufacturing, and Controls (CMC) analytical tests for drug products for regulatory submissions (Investigational New Drug application). Reached out to and collaborated… Show more Serves as co-PI on grant for development of two products. Write NIH grants for continued funding.Wrote and submitted two Investigational New Drug (IND) applications in the eCTD format to the FDA for first in human clinical trials. Corresponded with the FDA following submissionDeveloped relevant Chemistry, Manufacturing, and Controls (CMC) analytical tests for drug products for regulatory submissions (Investigational New Drug application). Reached out to and collaborated with vendors and CROs when necessary for lab maintenance or CMC test outsourcing.Managed withdrawal of grant funds.Collaborated with sister company, Auritec Pharmaceuticals, to participate in NIH I-CORPS program to evaluate company business model and approach. Show less
