Viren Patel

About Viren Patel

I am currently working as an Operations Specialist (CDx/IVD Studies) & Principal Investigator for several CDx & IVD Studies in the Q Squared Solutions Clinical Trials Laboratory, Valencia, CA. In this role, I am coordinating global operational strategy and scientific support efforts in the context of Companion Diagnostics (CDx) clinical studies and In-Vitro Diagnostics (IVD) studies as well as overseeing several Molecular and Therapeutic Drug Monitoring CDx & IVD studies as a Principal Investigator at Q Squared Solutions.I have 32 years of vast research experience in Clinical Laboratory Science and Clinical Trials Research and Development and I also worked as a Global Senior Scientist in the Global Lab Standardization Department of Q Squared Solutions Clinical Trials. Possess in depth experience and knowledge of different Assay Platforms (PK Assay, Flow Cytometry, ELISA, Electrophoresis, Atomic Absorptions, RIA, TLC, HPLC, Gas Chromatography, Gas Chromatography Mass Spectroscopy, Nephelometry, ISE, Fluorescence Polarization and more).I have very good experience of Validations for Bio-markers & Cytokines Assays, data analysis and writing of Validation Reports including writing of Technical Methods. Experience and know-how of Pharmacokinetics (PK) Assays Validations for IGIV Drugs.I mentored and guided scientists in the laboratory for the validation of Bio-marker RUO Assays as well as many CAP/CLIA Validations for Clinical Chemistry Assays including Hematology, Immunology and Molecular Biology.I’m always interested in hearing from former colleagues, managers, or just interesting creative folk, so feel free to contact me if you’d like to connect.

Experience

1. Principal Scientist and Regulatory Operations (Cdx Ivd)

   Q Solutions

   Mar 2019 — Present · CA, US

   As CDx Operations Specialist, working with the Global CDx Discipline Director, Scientific Advisor, and IVD Alliance Director to execute and build the CDx & IVD Studies as well as active participation in the development and implementation of Company’s CDx operating model.Working closely with Q2 CDx Global Team members and the laboratories to ensure execution of CDx clinical trial studies and testing of the patient samples and liaising with key Lab Operations Experts as necessary to discuss implantation of CDx and IVD studies Protocols, assays’ technologies as well as sponsors suggested custom processes/practices.Working to facilitate collaboration, cooperation, sharing information and team work for the CDx/IVD studies execution among the Q2 Solutions laboratories and the alliance laboratory along with supporting company initiatives to improve employee engagement to positively impact operational results and customer satisfaction for the CDx/IVD studies.

Education

• B.A. College of Agricultural & Biological Sceinces

  Master's degree, Environmental Toxicology & Pathology

  1982 — 1984

• B.A.College of Agricultural & Biological Sciences

  Bachelor's degree, Biological and Physical Sciences

  1978 — 1982

• B.A. College of Agricultural & Biological Sciences, Gujarat, India

  Doctor of Philosophy (PhD), Environmental Toxicology & Pathology

  1984 — 1988