I am a driven molecular/cancer biologist, and product development scientist specializing in utilizing next gen sequencing technologies to improve the treatment of patients.Experienced leader in designing, overseeing, and completion of multiple for IVD and RUO product verification and validation efforts in both the liquid biopsy and tissue spaces. I've worked closely with regulatory affairs and marketing in the FDA 510(k) process for the first two cleared distributed NGS kit (PGDx elio tissue complete and PGDx elio plasma focus Dx). I was involved in preparing multiple 510k submission sections, addressed many FDA deficiencies, data analysis/summary, and in the negotiations with the FDA on labeling. I'm a strong believer in teamwork, but each individual in the team needs to be at their best for the team to succeed. I have 10+ years of experience in managing multiple projects and mentoring >5 people at a time with over a year of experience in a CAP certified laboratory and biobank.I believe scientists need to play many roles in society including; advising policy makers, development of young scientists, and the effective communication with the general public.I've started to embark on a new venture by working towards starting a company to enable the development of plasma based cancer invitro diagnostic assays filling the gap in the high levels of sample needs for the development process.