Monika Mahesh

About Monika Mahesh

I am passionate about working towards developing novel diagnostics and therapeutics for human disease. I have expertise in project management and product development. I have worked with diverse teams of researchers to complete complex research aims, which have influenced experimental processes and met stakeholders’ goals worldwide. My technical skills and knowledge include in-vitro diagnostics, biomarker assays, bioanalysis (RTqPCR), genetic engineering, RNA biology, immunology, cell and molecular biology.

Experience

1. Senior Research Scientist

   Infinixbio

   Aug 2022 — Present · Columbus, OH, US

   Lead assay developmental team, to design antimicrobial susceptibility testing as a universal platform starting from proof of concept.• Design and execute R&D pipelines for projects related to in-vitro diagnostics (IVD) focusing the molecular detection at RNA, DNA & and protein levels, using live pathogens. • Led a multidisciplinary team of Key opinion leaders, subject matter experts, software engineers, investors, downstream engineers, CRO, CMO, and certified diagnostics labs. • Received outstanding recognition for collaborating, planning, and running projects, and creating value with stakeholders. • Compiled Instruction for use (IFU) document for LDT (laboratory-developed test) testing at different CLIA-certified labs. • Key role in technology transfer and training CLIA labs for LDT training. • Worked on therapeutics biologics as potential drugs to treat ALS using a luciferase-based reporter assay.• Designed plasmids for protein bioproduction, expression, extraction, & bioanalysis of biologics for cancer treatment. • Studied the effect of “unique peptide’s” antiaging properties using a fluorescence-based detection assay.• Independently prepared sections of the Design history file for Class II type medical devices FDA (510K) submission.• Scientific writing experience- 11 project proposals, 8 final reports, 10+ proposal addendums, and SOP.• Hired two research scientists and three research associates. • Managed the budget and resource prioritization, allocation, and realization. Purchasing and vendor handling. • Client handling, management, and timely project update reporting through in-person and online meetings.

Education

• Birla Institute of Technology and Science, Pilani

  Doctor of Philosophy - PhD, Molecular Microbiology

• University of Rajasthan

  Bachelor of Science (BSc. Botany Hons.), Gold Medalist, Botany Honours

• University of Rajasthan

  Master's degree, Botany Honours (Plant Pathology)