Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

HIMANGI R. JAYAKAR, PhD

Biomedical Professional
Bridgewater,NJ

Summary

Biomedical Researcher with 13 years of experience conducting research to study human diseases and drive healthcare improvements. Critical thinker with background developing and improving methodologies, data analysis and reporting. Extensive background in Infectious Diseases, quality control, assay development, data management & analysis and process development. An avid reader, a team player with excellent organizational skills, passionate about science and enthusiastic about learning new skills. Seeking the next step in career growth and learning in the Clinical Research field.

Overview

15
15
years of professional experience
7
7
years of post-secondary education
1
1
Certification

Work History

Quality Manager

SAAZ MICRO INC
Thousand Oaks, USA, USA
04.2018 - Current
  • Spearheaded and successfully led the company through four AS9100D audits since initial certification
  • Established and customized the Quality Management System for the company compliant with AS9100D Aerospace standards
  • Authored SOPs, trained personnel on Quality systems
  • Ensured compliance with SOPs through regular internal audits
  • Established process improvement methods to ensure high levels of quality and compliance during all stages of technical development and production
  • Organized procurement process and inventory management systems
  • Track and maintain data on vendors to maximize product quality and performance
  • Develop processes and ensure adequate project documentation
  • Track and maintain data on vendors to maximize product quality and performance.
  • Updated quality control standards, methods and procedures to meet compliance requirements.
  • Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
  • Managed and archived quality documentation and participated in internal and external quality audits.
  • Devised specifications for processes.

Preclinical Research Scientist

PFIZER INC
San Diego, USA, USA
10.2012 - 06.2014
  • Developed and implemented “Organ-on-chip” models using cutting edge microfluidics technology
  • Performed preliminary and exploratory data analysis for 3D invitro model studies into Blood-Brain-Barrier (BBB) permeability and Renal Toxicity.
  • Interacted and forged relationships with cross functional teams across multiple sites to evaluate these invitro models.
  • Performed research into study topics to increase knowledge and to provide valuable contributions.

Senior Research Fellow

THE SCRIPPS RESEARCH INSTITUTE
San Diego, USA, USA
12.2010 - 07.2012
  • Studied host-pathogen interactions and resistance to interferon signaling using Lymphocytic Choriomeningitis Virus (LCMV) as a virus model
  • Exercised Used reverse-genetics methods to establish novel mutant viruses of LCMV as tools for the studying the pathophysiology of the disease caused by the virus
  • Designed siRNA screens to identify novel mutants of nucleoprotein which lack host antagonistic functions.
  • Oversaw studies, documented data and extrapolated results.

Postdoctoral Research Fellow

THE UNIVERSITY OF TENNESSE HEALTH SCIENCE CENTER
Memphis, USA, USA
07.2005 - 05.2010
  • Contributed to and actively participated in research conception, design and execution to address defined problems.
  • Vaccine projects: Led the design and implementation of studies to develop Vesicular Stomatitis Virus (VSV) based viral mutants as candidate recombinant vaccines
  • Oncology projects: Developed new attenuated VSV viral vectors for application in treatment of glioblastoma and other glial tumors
  • Collaboration project with Department of Neuroscience at UTHSC
  • Viral Vector Development: Produced Developed VSV viral vectors that specifically target prostate tumors in collaboration with Dept of Urology, University of Pittsburg
  • Bacterial Pathogenesis: Designed and performed invivo murine studies in host-pathogen interactions for Tularemia, a bacterial disease
  • Developed a vaccine candidate for pathogenic FTularensis type A virulent strain SchuS4
  • Hands- on experience working in Biosafety level-3 (BSL-3) lab with animal models of respiratory disease.

Research Scientist

GTX INC
Memphis, USA, USA
01.2002 - 07.2005

Therapeutic Area Lead: Led the preclinical team in production of GLP test material in the anti-HIV therapeutic program

Led the development of attenuated VSV based vectors for gene therapy (patent filed in 2003)

Collaboration: Partnered with UTHSC scientists for development of VSV based oncolytic viral vectors. It led to a three-year collaborative project and a successful STTR I grant (a one-year, $100,000 award) and one publication.

Regulatory: Discussion with FDA about development of the VSV vectors for IND filing for planning of the pre-clinical development package

Publications: Published an invited review article on Rhabdovirus budding for a special issue of Virus Research.

Education

Ph.D - Microbiology and Immunology

The University of Tennessee Health Science Ctr
Memphis
06.1996 - 12.2001

Masters - Biotechnology

The University of Pune
Pune, INDIA
06.1994 - 06.1996

Skills

Hands-on experience with REDCap, Smartsheets, Microsoft Suite

ISO9001 and AS9100 quality standards

Excellent Verbal and written communications

Good Laboratory Practices (GLP)

Quality assurance

Collaboration and Team

Data analysis

Familiar with ITAR, Export control

Proactive Problem solver

Certification

Clinical Research Data Management Certification, [Vanderbilt University]

Timeline

Clinical Research Data Management Certification, [Vanderbilt University]

11-2021

Quality Manager

SAAZ MICRO INC
04.2018 - Current

Preclinical Research Scientist

PFIZER INC
10.2012 - 06.2014

Senior Research Fellow

THE SCRIPPS RESEARCH INSTITUTE
12.2010 - 07.2012

Postdoctoral Research Fellow

THE UNIVERSITY OF TENNESSE HEALTH SCIENCE CENTER
07.2005 - 05.2010

Research Scientist

GTX INC
01.2002 - 07.2005

Ph.D - Microbiology and Immunology

The University of Tennessee Health Science Ctr
06.1996 - 12.2001

Masters - Biotechnology

The University of Pune
06.1994 - 06.1996
HIMANGI R. JAYAKAR, PhDBiomedical Professional