Profile Details

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Hire Dr. Harendra C.

United States

USD 100 /hr

Clinical NGS I Molecular Diagnostics । Virology I CLIA/CAP Lab Operations I Assay Validation I Antiviral Development

Profile Summary

Experienced leader in research & development, laboratory operations and compliance, analytical assay development/validation with solid background and expertise in virology, aseptic cell culture, and molecular biology in biotech industry. • Directed operations of CLIA/CAP laboratories offering PCR & NGS based diagnostic assays • Established NGS lab and optimized semi-automated workflow for COVID-19 surveillance and hybridization capture-based targeted sequencing workflow for oncology testing from liquid biopsy (cfDNA target) • Established high-complexity CLIA lab for qPCR based molecular diagnosis of COVID-19 • Developed and qualified molecular analytical assays (PCR, qPCR, NGS) • Validated PCR and NGS based assays according to CAP/CLIA guidelines (LDT) • Led the laboratory through successful CLIA inspection • CAP inspector for molecular pathology and inspected Molecular Diagnostic laboratories Molecular virologist by training, with 10+ years hands on experience with viruses (RSV, hMPV, FLU, WNV, DENV, and CHIKV) and cell culture (adherent and suspension, primary and established and stem cell culture), molecular biology, virus propagation, purification and characterization in BSL-2 and BSL-3 environment, data analysis & interpretation, troubleshooting. I have developed molecular & cell-based analytical assays (PCR, qPCR, NGS, ICC, IHC, immune-purifications, plaque assays), verified and validated per project needs. As the lab leader, I direct day-to-day operations of CAP/CLIA laboratories. Provide technical leadership and supervision to laboratory staff ensuring compliance, staff competency, QC, root cause analysis for adverse incidents and CAPA. Expertise in drafting analytical bench testing protocols, SOPs & technical docs for FDA and other regulatory submissions, innovative solutions for process improvement, workflow optimization and capacity building, defining project scope, cost estimation and timelines SBIR Grant proposal development, Research Manuscript/Review Article Drafting. Regenerative Medicine, Tissue engineering, 3D Bio-printing, Biomaterials, scaffold, bio-ink development, stem cell culture, Human induced pluripotent stem cell (hiPSC) culture, Cardiomyocyte generation, cell based printing. Extensive hands-on experience with West Nile Virus, Dengue Virus, Chikungunya Virus, SARS Coronavirus, Influenza Virus, Respiratory Syncytial Virus, Human Metapneumovirus, Alpha-viruses, and HIV. Expertise: NGS I Clinical NGS I qPCR/PCR I CAP/CLIA Laboratory Operations I CAP/CLIA Laboratory set up I Lab Readiness for regulatory audits I Writing refulatory policy and Procedures I Analytical Bech Testing Protocols I Shelf Life Study Protocols I Stability Protocols I Infectious Diseases Plaque Assay, TCID50, Virus Neutralization, PRNT, ELISA, Nucleic Acid & Antigen/Antibody detection assays, Immunofluorescence, Virus propagation/purification and characterization, Protein expression/purification, Process Development, Exosome purification & characterization, Antibody production/Purification, Affinity Chromatography/FPLC, RT-PCR, qRT-PCR, and Multiplex-PCR. 3D Bio-printing, bio-ink formulation, stem cell culture, cell based printing, Cardiomyocyte generation. Extensive Biosafety Level 2+ & Biosafety Level 3 work experience.

Subject Matter Expertise

• ★ Virology
• ★ PCR
• ★ COVID-19
• ☆ Immunoassay
• ☆ Stem Cell Research
• ☆ Biotechnology & Bioengineering
• ☆ Recombinant Protein Expression
• ☆ Bioprinting
• ☆ Microscopy
• ☆ Fluorescence Microscopy
• ☆ Cell Culture
• ☆ Tissue Engineering
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Respiratory Syncytial Virus (RSV)
• ☆ West Nile Virus
• ☆ Chikungunya
• ☆ Dengue
• ☆ Clinical Laboratory Science
• ☆ Molecular Pathology
• ☆ Severe Acute Respiratory Syndrome (SARS)
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Concept Development
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Regulatory Writing
• ☆ Nonclinical Study Documentation
• ☆ Technical & Scientific Writing
• ☆ Manuscript & Journal Article Writing
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Grant Writing
• ☆ 3D Printing/Additive Manufacturing

Services

• Writing
• Research
• Consulting
• Product Development

Writing Non-Medical Regulatory Writing, Technical Writing

Research Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Stability/Shelf Life Testing, Product Validation, Quality Assurance & Control (QA/QC), Concept Development

Work Experience

Director Laboratory Operations

HelioGenomics

May 2022 - Present

HelioGenomics

May 2022 - Present

Director of Laboratory Operations

Shield Illinois

January 2021 - April 2022

Manager Laboratory Operations

Baylor Genetics

August 2020 - November 2020

Senior Scientist

BIOLIFE4D Corp

October 2019 - June 2020

Senior Scientist

BRHMS LLC

October 2018 - October 2019

Postdoctoral Research Fellow

University of Texas Medical Branch

December 2013 - February 2017

Postdoctoral Research Associate

Texas Tech University Health Science Center

September 2010 - November 2013

Education

PHD

All India Institute of Medical Sciences

- Present

PhD

All India Institute of Medical Sciences (AIIMS), New Delhi India

January 2005 - March 2011

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

Harendra Chahar, Rob E. Carpenter, Vaibhav Tamrakar, Tyler Vine, Rahul Sharma, Gerald Mboowa (2022). Confirming Multiplex RT-qPCR Use in COVID-19 with Next-Generation Sequencing: Strategies for Epidemiological Advantage . Global Health.

Zhao Y, Chahar HS, Komaravelli N, Dossumbekova A, Casola A (2019). Human metapneumovirus infection of airway epithelial cells is associated with changes in core metabolic pathways . Virology.

Chahar HS, Corsello T, Kudlicki AS, Komaravelli N, Casola A (2018). Respiratory Syncytial Virus Infection Changes Cargo Composition of Exosome Released from Airway Epithelial Cells . Scientific reports.

Chahar HS, Bao X, Casola A (2015). Exosomes and Their Role in the Life Cycle and Pathogenesis of RNA Viruses . Viruses.

Preeti Bharaj, Chahar HS, Alozie OK, Rodarte L, Bansal A, Goepfert PA, Dwivedi A, Manjunath N, Shankar P (2014). Characterization of programmed death-1 homologue-1 (PD-1H) expression and function in normal and HIV infected individuals . PloS one.

Choi JG, Mun SH, Chahar HS, Preeti Bharaj, Kang OH, Kim SG, Shin DW, Kwon DY (2014). Methyl gallate from Galla rhois successfully controls clinical isolates of Salmonella infection in both in vitro and in vivo systems . PloS one.

Chahar HS, Chen S, Manjunath N (2012). P-body components LSM1, GW182, DDX3, DDX6 and XRN1 are recruited to WNV replication sites and positively regulate viral replication . Virology.

Chen S, Chahar HS, Abraham S, Haoquan Wu, Pierson TC, Wang XA, Manjunath N (2011). Ago-2-mediated slicer activity is essential for anti-flaviviral efficacy of RNAi . PloS one.

Broor S, Chahar HS, Samander Kaushik (2009). Diagnosis of influenza viruses with special reference to novel H1N1 2009 influenza virus . Indian journal of microbiology.

Chahar HS, Preeti Bharaj, Dar L, Guleria R, Kabra SK, Broor S (2009). Co-infections with chikungunya virus and dengue virus in Delhi, India . Emerging infectious diseases.

Preeti Bharaj, Sullender WM, Kabra SK, Mani K, Cherian J, Tyagi V, Chahar HS, Samander Kaushik, Dar L, Broor S (2009). Respiratory viral infections detected by multiplex PCR among pediatric patients with lower respiratory tract infections seen at an urban hospital in Delhi from 2005 to 2007 . Virology journal.

Broor S, Preeti Bharaj, Chahar HS (2008). Human metapneumovirus: a new respiratory pathogen . Journal of biosciences.

Preeti Bharaj, Chahar HS, Pandey A, Diddi K, Dar L, Guleria R, Kabra SK, Broor S (2008). Concurrent infections by all four dengue virus serotypes during an outbreak of dengue in 2006 in Delhi, India . Virology journal.

Pandey A, Diddi K, Dar L, Preeti Bharaj, Chahar HS, Guleria R, Kabra SK, Broor S (2007). The evolution of dengue over a decade in Delhi, India . Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.