Presha Shah Email and Phone Number
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Project leader and Senior Scientist with 6+ years’ experience in multiplex assay development for cancer diagnosis on various NGS platforms. Demonstrated track record in developing NGS assays with multiple gene targets and successfully developed/launched 510(K), CE-IVD, RUO and LDT assays.● Technical lead on various projects working closely with members of R&D, biostatistics and bioinformatics departments. ● Developed automated extraction and concentration/purification method for improved yield and quality of DNA from bone marrow and peripheral blood samples.● Optimized assay performance for use with different sample types, including clinical samples, for Leukemia and Lymphoma diagnostic and MRD assays.● Expertise in troubleshooting and mitigating risks through coordination with other departments including QC, RA and Manufacturing.● Collaborated with Business Development for design and demonstration of assay performance for presentation to external companies for partnership.● Worked closely with marketing in drafting, reviewing and finalizing package inserts for various cancer diagnostic products.● Trained and managed a highly productive team to be diligent and enthusiastic to meet deadlines and project goals.● Expertise in effective communication with experience in presentations to executives, project team members, collaborators and conferences. ● Outstanding communicator of experimental results in order to gain approval for product commercialization in the biotech industry.● Strong organization and communication skills with the ability to communicate complex ideas and theories with clarity at all levels of an organization.
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Senior Manager, Product DevelopmentInvivoscribe Mar 2022 - PresentSan Diego, California, Us -
Manager, Product DevelopmentInvivoscribe Jan 2020 - Mar 2022San Diego, California, Us● Technical lead for development of NGS project focusing on Illumina NextSeqDx platform for MRD detection that includes feasibility, verification and validation. ● Supervised and managed team of scientists and development associates. Provided technical guidance for experiment designing, optimization and troubleshooting.● Successfully developed controls for MRD assay using cell lines and synthetic gBlocks that met the product requirements and successfully transferred into manufacturing.● Lead collaborator with external partners to perform pilot study with blinded samples with MRD assay.● Worked with regulatory and quality personnel to draft and finalize design control documents along with protocols and reports for feasibility and validation of the assay, SOPs for cell counting, cell to cell contriving, DNA extraction and purification/concentration for manual and automated methods on the KingFisher instrument. -
Scientist IiInvivoscribe Feb 2018 - Jan 2020San Diego, California, Us* Launched LymphoTrack Assay for T-Cell Receptor Beta on Illumina's MiSeq Platform (RUO and CE-IVD) - Successfully carried out analytical and clinical validation of the assay - Worked closely with quality and regulatory to meet all the requirements - Helped marketing with launch of the assay in US and Europe -
Scientist IInvivoscribe May 2016 - Feb 2018San Diego, California, Us° Designed and developed sequence based lymphotrack assay ♦ Designed primers for T-cell receptor regions involved in VDJ rearrangements.♦ Designed and performed experiments to determine feasibility of the assay in a multiplex reaction that involved individual and multiplex primer testing with different cell lines, FFPE samples, peripheral blood, and LOD panel.♦ Collaborated with bioinformatics scientist for lymphotrack software development. ♦ Carried out design transfer for purchasing oligonucleotides and master mix formulations.° 510K submission ♦ Investigated existence of PCR Bias in a multiplex reaction for an FDA submission.° Trained on all aspects of SOPs for product design and development to meet ISO standards and FDA QSR requirements -
Scientist ISequenom, Inc. May 2015 - May 2016Westborough, Massachusetts, UsNon-invasive prenatal diagnosis using next generation sequencing. ° Successfully determined root source of aberrant GC Bias caused by NEB library prep components. ° Effectively carried out size selection, quantification, library preparation, sequencing, and distribution of Maternity GENOME and MaterintyT21 plus controls. ° Productively scaled, optimized, and verified 12-plex to 24-plex that not only brought down the MaternityT21 plus assay cost significantly but also exceeds the through put significantly.° Developed positive sequencing control for each well of the library prep plate in NGS that would help in monitoring the cause of aberrant data for further downstream analysis. This project includes the designing of barcodes, amplicons, generating libraries from these amplicons, and validation for their use as controls in DNA extraction, library preparation, cluster generation, and sequencing.°Designed and developed oncology target capture assays. -
Ph.DUniversity Of California, Riverside Sep 2010 - Apr 2015Riverside, Ca, UsTo identify active class II DNA transposons in Ae. aegypti through bioinformatics analysis. These transposons are then tested to determine their activity in somatic cells and in the germ-line of D. melanogaster and Ae. aegypti. Transposons with activity higher than or even approachable to current most active transposon piggyBac are then tested for its remobilization activity. Transposon with good mobilization rate might serve as a genetic tool that can be utilized to manipulate genome of the tropical disease vectors. ° Discovered a Mutator superfamily class II DNA transposon “Muta1”. ° Somatic assays and germline transformation experiments showed Muta1 to be active in D. melanogaster and Ae. aegypti. ° Remobilization experiments determined Muta1 to be able to move in the genome of D. melanogaster and Ae. aegypti once integrated. ° Current research is focused on studying relationship between Muta1 transposon and piRNAs that are known to be involved in regulation of transposons. -
Ms DissertationFoundation For Research In Genetics And Endocrinology Jun 2008 - Aug 2008Studied patients sample to diagnose Fanconi's Anemia, where cells culture that is been exposed with a DNA intrastrand cross-linking agents such as diepoxybutane (DEB) or mitomycin C (MMC) is checked for chromosomal aberration like breaks, rearrangements, radials and exchanges.
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Undergraduate Research ScholarSt. Xavier'S College Jul 2006 - May 2007Developed protocols for production of good quality vermicompost using worms and household waste, cultivate fungi and oyster mushroom in hot and humid environment.
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Undergraduate EntrepreneurSt. Xavier'S College Jul 2006 - May 2007Kathmandu, NpServed as a member of administrative team at Xplant, an undergraduate student run company based on manufacture of plant tissue cultured products and developed techniques to carry out “Micro propogation of Osimum sanctum (Tulsi)”.
Presha Shah Skills
Presha Shah Education Details
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University Of California, RiversideBiochemistry And Molecular Biology -
Gujarat UniversityHuman/Medical Genetics -
St. Xavier'S CollegeBiochemistry/Biotechnology
Frequently Asked Questions about Presha Shah
What company does Presha Shah work for?
Presha Shah works for Invivoscribe
What is Presha Shah's role at the current company?
Presha Shah's current role is Senior Manager, Product Development at Invivoscribe.
What is Presha Shah's email address?
Presha Shah's email address is pr****@****ail.com
What schools did Presha Shah attend?
Presha Shah attended University Of California, Riverside, Gujarat University, St. Xavier's College.
What are some of Presha Shah's interests?
Presha Shah has interest in Science And Technology, Education, Disaster And Humanitarian Relief, Health.
What skills is Presha Shah known for?
Presha Shah has skills like Molecular Biology, Biochemistry, Cell Culture, Pcr, Bioinformatics, Protein Purification, Confocal Microscopy, Microsoft Office, Biotechnology, Life Sciences, Genetics, Polymerase Chain Reaction.
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