Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Affiliations
Certification
Languages
Timeline
PROFESSIONAL TRAINING
Peer-Reviewed Publications
Honors & Awards
Generic

Mirajul Kazi

Timonium,USA

Summary

Scientist with a proven track record of R & D experience in the field of infectious and systemic disease with more than two years of working experience in the pharmaceutical industry as an Analytical Development Scientist. Proven track record of scientific accomplishments and innovations in epithelial-linked (i.e., GI, renal, respiratory) systemic disease (i.e. hyperuricemia, sterile and non-sterile inflammation) and complexity of disease progression utilizing animal models correlating with hypotheses generated from cloud-based multi-omics discovery platforms (i.e. ROSALIND for nanoString, BASEPAIR for RNA Ses, DAVID bioinformatic esources). My MS in Regulatory Science (Pharma) and the METRUM Research Institute course on ADME, DMPK, and the identification of predictive disease models in non-clinical settings have equipped me with valuable knowledge. I have considerable knowledge in Metabolic clearance assay, drug metabolism pathways, and inhibition/activation of the metabolic assay.

Demonstrate a high drive and initiative, logic and decision-making abilities, and critical thinking skills. Multiple research publications in quality journals include Nature Communication. I possess supervisory capabilities for subordinate staff in the research laboratory and have a proven track record of mentoring Ph.D. students.

Overview

16
16
years of professional experience
1
1
Certification

Work History

Associate Scientist (Analytical)

Catalent Pharma Solution
05.2022 - Current

OUTSTANDING ACCOMPLISHMENT: Contribute to effective methods, assay validation, robustness study, and scientific discussion to keep the analytical department and Catalent at the state of the art to produce positive outcomes for clients by generating key data packages and scientific strategies. I have recently introduced a new workflow of AAV capsid lysis to boost accurate, reliable method of AAV titration that is superior to current practice of AAV capsid lysis

Research Associate Faculty (Full-Time)

University of Maryland School of Medicine
12.2016 - 04.2022
  • Develop and execute human cell culture model systems to elucidate mechanisms of action for potential therapeutic candidates.
  • Independently and proactively design experiments and interpret and track results, organize, summarize, and present data
  • Analysis and generate teas able hypothesis from RNA-seq data of enterocytes using the cloud-based platform (BASEPAIR, ROSALIND for nano string data), GO-term analysis using NIH DAVID program for data visualization and using
  • Design primers for conventional PCR (using Bio-Rad T100 Thermal Cycler) and quantitative PCR (using Quant Studio 3 of applied biosystems with SYBER green) for mammalian gene amplification.
  • Perform bioassay for measurement of uric acid (Fluorometer), glucose, insulin (ELISA based), fructose (Colorimetric), and cytokines (ELISA based) in biological fluids from me or the cell culture supernatant.
  • Isolation and characterization of active molecules using HPLC, Mass spectrometry: DOI: 10.1080/13880209.2021.1949357
  • Isolation of immune cells from mouse blood and intraepithelial lymphocytes of LPS induction for FACS analysis to characterize T-cell polarization under the influence of hyperuricemia (Using Cytec Aurora cytometers; 3 lasers (488, 405, and 640 nm) of 23 colors.
  • Dose and time kinetic study of drug transport using ex-vivo intestinal tissue and in vitro Caco-2 cells
  • Immunofluorescence study using confocal microscopy for localization of membrane proteins and their interaction with scaffold protein for mechanistic study as well as for barrier function study
  • Demonstrate work independently and creatively in a fast-paced environment and contribute to discussions in project team meetings.
  • Collect and organize professional contributions, including written works and research data from various co-authors for publication and NIH research grant writing.
  • Assimilate and evaluate in-house and publicly available data and apply creative thinking in support of new target identification and evaluation and ongoing projects.
  • Provide scientific insights based on knowledge and experience and deliver robust results to enable decision-making for new lines of work.

OUTSTANDING ACCOMPLISHMENTS: (1) I am the first scientist to discover how genetic causes of intestinal urate transport failure produce chronic hyperuricemia. In contrast, an acute increase in soluble urate, on the other hand, regulates the anti-inflammatory response and protects the host against infection when an infection occurs. [10.1038/s41467-020-16525-w] (2) First demonstrated that SARSCoV2 infection caused intestinal enterochromaffin cell hyperplasia, which could elevate 5HT. 5HT may be a crucial determinant of COVID19 associated diarrhea, alveolar flooding/Acute Respiratory Distress Syndrome, which has significant implications for COVID19 treatment [https://doi.org/10.1096/fasebj.2022.36.S1.0R556].

Scientist- D

National Institute of Cholera and Enteric Diseases (NICED)
08.2010 - 11.2016
  • I developed and led an innovative and intensive R&D research program in the field of gastrointestinal-related infectious disease, focusing on epithelial transport and barrier function, intestinal inflammation, cystic fibrosis, intestinal hypodynamic disorder, signal transduction, and translational research.
  • I was responsible for independently organizing, analyzing, and writing reports within the assigned scientific area. Read, interpreted, analyzed, and condensed materials from various sources for presentation.
  • I was responsible for independently operating the R&D laboratory and securing grants to support its activities.

OUTSTANDING ACCOMPLISHMENTS: (1) We have established that zinc could be an alternative strategy to reduce Shigella-induced inflammatory responses and epithelial barrier dysfunction [https://doi.org/10.1152/ajpgi.00092.2018]. We found a substance similar to cucurbitacin in cucumbers that activates TMEM16A chloride channels and could help treat cystic fibrosis and problems with slow-moving intestines.

Instructor of Medicine

Johns Hopkins University, Baltimore, MD
08.2009 - 07.2010

Education

Master of Science - Regulatory Science (Pharmaceuticals)

University of Maryland

Doctor of Philosophy - Gastrointestinal Physiology

Jadavpur University, India

Master of Science - Human Physiology

Vidyasagar University, India

Skills

  • Plan and work independently and generate original ideas that address needs of the sponsor
  • Ability to develop in-depth scientific knowledge in research focus
  • Fast learner, can quickly adapt to changing project needs
  • Demonstrate significant accomplishment in R & D, and conception of new lines of work
  • Lead and optimize efforts to build multiple projects and facilitate collaboration in the network of scientists
  • Demonstrate time management skills, flexibility and willingness to change ways of working
  • Ability to write SOPs, scientific reports, data analysis, interpretation, and scientific presentation of various formats
  • Conceptualize and design in vitro and in vivo assay developments for pre-clinical study
  • Experience in developing and optimizing assays to assess the biological activity of bioproducts
  • Mammalian cell culture (intestinal stem cells, lung, renal epithelial cells)
  • Viral, bacterial, and parasitic infection model based on epithelial cells (2D and 3D model)
  • In vivo systemic inflammation model (sterile & non-sterile inflammation) development Isolation of immune cells from human and mouse blood for FACS analysis
  • ELISA to detect host cell impurities for biotherapeutics and manufacturing
  • Statistical tactics utilizing JMP, Prism, Origin for data analysis and method assessment to support test method validation and transfer
  • Biochemical-based assay for cytokine profiling, uric acid, fructose, insulin, Growth factor, intestinal transport function study (ex vivo, in vivo)
  • Expertise in vitro assay development for preclinical study
  • Cell-based characterization approaches such as gene expression, protein localization, and expression, and downstream signaling or functional pathway endpoints
  • Experienced with ddPCR, Octate ELISA, qPCR for AAV genomes for development study, pre-validation IP matrix, linearity, bridging study and reference standard qualification and stability
  • HPLC and LC-MS data interpretation and identification of the novel molecule
  • RNA, DNA, protein purification and analysis, transfection, lentiviral particle purification, and transduction
  • QPCR, conventional PCR assay, RNA Seq data analysis to generate a teas able hypothesis using cloud-based multi-omics discovery platforms (ROSALIND, BASEPAIR)
  • Electrophysiology for ion channel and barrier function study for renal and gastrointestinal therapeutics
  • Design, execute experiments, review data and conduct analysis
  • In vitro model of drug transport using intestinal epithelial cells

Accomplishments

  • Achieved [Result] by introducing [Software] for [Type] tasks.

Affiliations

  • Regulatory Affairs Professional Society (RAPS), Rockville, Maryland, USA
  • Board Member of the Physiological Report, UK
  • Member, University of Maryland School of Pharmacy Alumni, 20 N Pine St, Baltimore, MD, USA
  • Life Member Indian Science Congress Association
  • Past member of the American Gastroenterological Society
  • Past member of the American Physiological Society

Certification

  • Drug Hunting – The Science of Making New Medicine from Novartis via Coursera, USA Feb 2025
  • Clinical Trial: Good Clinical trial Practice from Novartis via Coursera Jan 2025 [https://coursera.org/share/a4a846e15dcda773d19da0777792337cb6]
  • RAPS Certification on the Role of the Regulatory Professional, 03Jan25 [pdfconverter.aspx]
  • Generative AI: Introduction and Application from IBM via Coursera Jan2025.
  • Artificial Intelligence and Strategy from Rutgers University, New Jersey Oct 2024.
  • Pharmaceutical and Medical Device Innovations of University of Minnesota, Carlson School of Management. [https://coursera.org/share/0118d2bba665bc779175107dfc3304a5]
  • Critical Thinking Skills for Professional from the University of California, Davis via Coursera: https://coursera.org/share/527ed6b6c50e44d48671404e9c3c739
  • CGMP: Introduction to Good Manufacturing Practice - An Abridged Course from Biopharma Institute, New Jersey, USA [Certificate of Completion (biopharmainstitute.com)]
  • CGMP: Quality Assurance and Quality Control (course code – GMP-09) from Biopharma Institute, New Jersey, (credit hours 2.0). [ View Certificate (biopharmainstitute.com)]
  • Introduction to Drug Safety and Pharmacovigilance – A bridge course (Course code AV00) from Biopharma Institute, New Jersey, USA (Credit hours 0.5)[ Certificate of Completion (biopharmainstitute.com)].
  • GxP: Good Practices (GxP) in Drug Development and Manufacturing (Course Code GXP01) from Biopharma Institute, New Jersey, USA (Credit hours 1.0 CPD) [Certificate of Completion (biopharmainstitute.com)]
  • Critical Thinking Skills for the Professional from the University of California, Davis via Coursera online learning [Oct 2024]

Languages

English
Professional Working

Timeline

Associate Scientist (Analytical)

Catalent Pharma Solution
05.2022 - Current

Research Associate Faculty (Full-Time)

University of Maryland School of Medicine
12.2016 - 04.2022

Scientist- D

National Institute of Cholera and Enteric Diseases (NICED)
08.2010 - 11.2016

Instructor of Medicine

Johns Hopkins University, Baltimore, MD
08.2009 - 07.2010

Doctor of Philosophy - Gastrointestinal Physiology

Jadavpur University, India

Master of Science - Human Physiology

Vidyasagar University, India

Master of Science - Regulatory Science (Pharmaceuticals)

University of Maryland

PROFESSIONAL TRAINING

  • GASTROENTEROLOGY DIVISION | JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE, Baltimore, MD Post-Doctoral Fellow, August 2004 – July 2009
  • DEPARTMENT OF DIGESTIVE DISEASES | SCHOOL OF MEDICINE | YALE UNIVERSITY, New Haven, CT Post-Doctoral Fellow, March 2003 – June 2004

Peer-Reviewed Publications

  • Hoque K.M., Eryn Eryn E. Dixon, Raychel M. Lewis, Jordyn Allan, Gregory D. Gamble, Amanda Phipps-Green, Victoria L. Halprin-Kuhns, Anne Horne, Lisa K. Stamp, Tony R. Merriman, Nicola Dalbeth, Owen M. Woodward. “The ABCG2 Q141K hyperuricemia and gout associated variant illuminates the physiology of human urate excretion.” 2020. Nature Commun. 11(1): 2767, doi: 10.1038/s41467-020-16525-w.
  • . Elevated 5-hydroxytryptamine in COVID-19 stimulates ANO1 mediated Cl secretion in lung and intestinal epithelial cells FASEB J, 36 (Suppl 1) 2022. https://doi.org/10.1096/fasebj.2022.36.S1.0R556
  • Hogue KM, Kuhns VP., Dixon E., and Woodward OM. Significant role for intestinal urate transporters in host defense. FASEB J. 34 (Suppl 1) 2020. https://doi.org/10.1096/fasebj.2020.34.s1.06487
  • Saha T, Aoun J, Sarkar P, Bourdelais AJ, Baden DG, Leblanc N, Hamlyn J, Woodward OM, Hogue KM “Cucumis sativus extract elicits chloride secretion by stimulating intestinal TMEM16A ion channel”. 2021; Pharmaceutical Biology 59(1): 1008 – 1015.


Honors & Awards

Session Co-Chair for Hebert Lecture of the Epithelial Transport Group (431) at the Experimental Biology Meeting in Orlando, FL, 2019, Early Career Investigator Award for scientific accomplishment, American Gastroenterological Council Chair at the DDW meeting, Washington Convention Center, June 2018., International Vaccine Institute and Bill & Melinda Gates Foundation grant award for the 52nd Joint panel conference on cholera and other bacterial enteric infections, Hatjai, Thailand, 2018., American Physiological Society’s Research Recognition Award (Junior Faculty Category) presented at the APS GI and Liver Section of Experimental Biology Meeting, San Diego, CA, 2014, Editorial Board members and reviewers of Physiological Report, American Journal of Physiology, Journal of Physiology
Mirajul Kazi