R&D Scientist II
Maine Molecular Quality Controls INC
Nithya Sivaji, has Master’s degree in Applied Microbiology and Bachelor’s degree in Microbiology from Periyar University. With more than twelve years of academic, industry research and development experience, she has developed numerous products that provide meaningful application in the field of Rapid Immunoassays (ELISA and Lateral Flow Assay) and Molecular Quality Controls for Molecular Diagnostic assays. She currently works as an R&D Scientist II at Maine Molecular Quality Controls, Inc. where she leads the design and development of innovative, high quality molecular control products generated in a cGMP facility.
Working together with molecular diagnostic partners and clinical laboratories, she designs and markets molecular controls for emerging In-Vitro Molecular Diagnostic assays tested across various inherited, oncological, and infectious diseases. Nithya is a demonstrated leader with strong project management abilities, achieving success by increasing the company’s productivity through process improvements and the creation of novel standard operating practices. She also contributes to quality assurance through validation of manufactured controls and seeing multiple products through FDA 510K submission. With skills ranging from Molecular cloning, transformation, transcription, Sanger Sequencing, designing qPCR & ddPCR assays, and in-depth statistical analysis. Nithya’s product development expertise within a quality management system has allowed for the generation of multiple DNA and RNA based controls used in both research and clinical assay monitoring today.