V Shyamala

Washington D.C. Metro Area United States

Molecular Diagnostics Consultant

Medical / Health Care / Pharmaceuticals

Experienced molecular assay developer to support FDA/EU approved products. Develop, implement, support assays in CLIA Reference labs for Clinical trials. Extensive experience in nucleic acid detection technologies. Several collaborations in the field of Blood testing for viral nucleic acids. Management skills towards personnel and timeline. Interface with investors, and manage Scientific Advisory Board. Represent R&D in core committee to interface with Regulatory, Marketing, and Customer training-support, Quality Control for FDA submission, and pre and post-approval product support. Evaluate emerging technologies, phased studies to establish merits of technologies. Numerous public...