Lakshmi G

Clinical Research - 20 Years of Experience - Near 98052


Clinical Research


Redmond, WA

Education Level:


Will Relocate:



CAREER HIGHLIGHTS * Expertise in innovative technology/Diagnostics: CLIA approved Laboratory Director extensive experience in assay/protocol development in molecular biotechnology. Experience in regulatory compliance, accreditation, credentialing, IRB and AICUC. * Serving as CLIA approved director for five high complexity laboratories. Extensive experience in quality control and quality assurance (successfully obtained multiple state licensures for diagnostic testing) * Worked with startup labs helping in setting the laboratory that included identifying biomarkers to be tested, developing assays and SOPs, creating documentation for regulatory compliance, identifying lab track systems that are conducive for the workflow, set up guidelines to proper storage and maintenance of specimens to retain specimen integrity. * As a director of molecular biology laboratory at the Puget Sound Blood Center (Bloodworks Northwest) helped the HLA lab transition from serology to molecular typing within the first two years from 1991 - 1995, the assay went through accreditation process and since replaced serology the Blood Center. * Rehired by Puget Sound Blood Center again in 2007 to transition Red cell serology to red cell genomics. * Assay development: * Developed Genomic Testing (both nucleotide sequencing and array technology using multiple SNPS in targeted amplifications) for Red Cell Antigens with ability to extensively genotype all 30 blood group including ABO and Rh blood groups (patent pending) * Trained and/or applied molecular methods including PCR, qPCR, NGS (training while at Blood Center and at Titan Molecular) and Cloning, high throughput sequencing at Blood Center. * * Hired a Clinical operational director initially to set up two high complexity molecular genetic testing (pharmacogenomics) at Washington Center for Pain Management and Ascendant Laboratories. Both labs were setup and functional within three months after hire and are CLIA (Ascendant laboratories waiting for CAP accreditation) approved and completely functional. Also serving as the laboratory director for both the laboratories currently. * Research: Basic, Clinical and Multicenter collaborations * Extensive research experience in Basic and Clinical applications, with grant support from multiple sources (NIH, NIAID, United States Armed forces, JRI among others). * Directed clinical research projects involving cellular and molecular biology assay methodologies, developing from developing assay protocols to compiling the results for research publications. * Extensive experience in regulatory aspects and well versed with IRB guidelines and HIPAA compliance. * Contract research/typing for Diabetes (National and international collaborations), transplantation and transfusion. * SEARCH study of Diabetes in Youth one of the examples where over 3000 DNA samples were tested for HLA class II in a record time of three months, including data reports. The study involved collection of blood samples, DNA extraction, distribution of samples for testing, and destruction of the samples following the completion of the study. * Role as program manager: Understanding the project parameters and when to scrap it or break it into smaller projects is instinctive, years of experience is an added advantage. I was cleared by PMI to appear for PMP certification test. * Invited speaker for numerous national and International presentation of Research highlights (over 65 peer reviewed publications) * A recipient of "Pioneer in Health Sciences award - 2010" from Northwest Asian weekly Foundation for developing cutting edge typing technology and for my on diabetes in various ethnic groups. * Washington State Governor appointed Commissioner - Chair, Health and human resources committee (Washington State Commission on Asian Pacific American Affairs) 2015 - 2018





CollapseJob Skills