.jpg "Nithya Sivaji, MS photo")
R&D Lab Supervisor/Scientist III
Maine Molecular Quality Controls, Inc.
Nithya Sivaji has a Master of Science degree in Applied Microbiology from Periyar University. With fifteen years of academic and industry research experience, she has developed numerous products that provide meaningful application in the field of molecular biology. She currently works as an R&D Lab Supervisor/Scientist III 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. She also oversees product support and development efforts to assist in identifying and resolving technical problems for a range of control products, whether they are in development or have been released, in compliance with cGMP following design control according to FDA 21CFR820, ISO13485 regulations. Collaborating with molecular diagnostic partners and clinical laboratories, she designs and markets molecular controls for emerging in vitro Diagnostic assays evaluated 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 is an expert in quality assurance, developing high-quality molecular controls to monitor all phases of molecular testing as required by FDA regulations and she also assists through validation of manufactured controls and seeing multiple products through FDA 510K submissions. With skills ranging from cloning, transformation, transcription, PCR, 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.