Summary
Overview
Work History
Education
Skills
Accomplishments
Degree
Research Publications
Timeline
Generic

SHIVANGI DHEBAR

Ahmedabad

Summary

Microbiologist with 10+ years of combined experience in pharmaceutical microbiology, biotechnology research, and regulatory compliance. Skilled in antimicrobial effectiveness testing, bacterial endotoxin testing (BET), sterility testing, and disinfectant validation. Strong expertise in method development, SOP preparation, validation protocols, microbial identification, and laboratory management. Successfully supported USFDA, EU, and internal audits without observations. Recognized for contributions to academic research, including genome sequencing and peer-reviewed publications.

Overview

13
13
years of professional experience

Work History

Senior Research Associate

Accuprec Research Lab
12.2023 - Current
  • Prepare standard operating procedures and review and revise existing SOPs for gap analysis.
  • Prepare validation as well as study protocols and their reports.
  • To review routine analysis of microbiology laboratory and ensure timely completion of all the activities.
  • Perform antimicrobial effectiveness testing.
  • Perform Bacterial Endotoxin Test (Drug substance, Raw material, Drug product, Medical device)
  • Sterility Testing (Drug product, Medical device)
  • Perform Disinfectant validation to establish hold time, contact time and effective concentration against various surfaces.
  • Execute various microbiological studies based on client requirements.

Executive

Emcure pharmaceuticals Limited
07.2018 - 11.2022
  • Prepare standard operating procedures and review and revise existing SOPs for gap analysis.
  • Prepare validation as well as study protocols and their reports.
  • Trained employees of existing plant as well as of other sites for microbiological testing and identification.
  • Prepare analyst qualification status calendar and plan annual performance evaluation of analysts as per calendar.
  • Faced major regulatory audits like USFDA and Europe audits as well as various internal audits without any observations.
  • Maintaining and data logging of EM isolates.
  • Perform identification of isolates as per pre-defined schedule using Vitek-2 Compact system.
  • Perform Operational qualification of Vitek-2 Compact system.
  • Preparation of annual summary for microbial identification.
  • Perform disinfectant validation to establish hold time, contact time and effective concentration against various surfaces using use dilution as well as surface challenge test.
  • Perform disinfectant efficacy testing using use dilution method in order to evaluate susceptibility of microorganism against routinely used disinfectants.
  • Perform Biological indicator challenge (BI) and maintain stock of BI.
  • Perform microbiological testing of water, raw material and in-process samples.
  • Perform MLT and Bioburden validations.
  • Receive microbiological samples for testing and distribution according to their optimum storage condition along with their entry in respective sample inward log.
  • Review of documents.
  • Manage documents for better traceability and Perform compilation of all testing data.

Senior Microbiologist

Concord Biotech Limited
01.2017 - 06.2018
  • Preparation and Handling of Microbial Culture Media.
  • Maintaining Microbial media stock record.
  • Storage of Media, additives, reagents under appropriate optimum conditions.
  • Handling of Analytical balance and pH meter.
  • Validation of autoclave (using Biological as well as Chemical indicator and Bowie Dick).
  • Microbial Limit Test (MLT) of finished product (API).
  • Environment Monitoring.
  • Perform routine lab activities and provide documentation by following GMP and GDP.
  • Faced major regulatory audits like USFDA and EU GMP as well as various customer audits.

Senior Research Fellow (SRF) in MicroExcon Project

Gujarat State Biotechnology Mission (GSBTM)
06.2014 - 01.2017
  • Performed Fatty Acid Methyl Esters (FAME) analysis of bacteria cultures using Gas Chromatograph- Mass Spectrometer (GC-MS).
  • Isolated cellulose degrading microorganisms from rhizospheric soil samples and found probable new species of microorganisms.
  • Provided services to academic institutions and industries- 16S r-DNA gene sequencing, lyophilization of cultures, residual DNA and RNA analysis, protein analysis and carbohydrate analysis.
  • Done 16S r-DNA gene sequencing of more than 500 cultures and one of the author in around 400 NCBI accession.
  • Done Whole Genome sequencing of bacterial isolates.

Junior Research Fellow (JRF) in MicroExcon Project

Gujarat State Biotechnology Mission (GSBTM)
08.2012 - 06.2014
  • Studied taxonomic and functional diversity of microorganism from petroleum muck using metagenomics approach as well as proposed hypothetical model for survival and syntrophy of microbes in hydrocarbon dominating environment.
  • Subculturing and large scale cultivation of Spirulina, Bacterial and algal pigment extraction as well as their application in textile dyeing.
  • It was an honor for me that one product, handmade paper bag dyed with algal pigment was placed in Vibrant Gujarat 2013.
  • Mentored couple of master’s students and to help them towards their thesis work.

Education

Master of Science - Microbiology

The Maharaja Sayajirao University of Baroda
Vadodara, Gujarat, India
01.2012

Bachelor of Science - Microbiology

Natubhai. V. Patel College of Pure and Applied Sciences (NVPAS)
Vallabh Vidyanagar, Gujarat, India
01.2010

Skills

  • Standard operating procedures
  • Method validation
  • Protocol and Report preparation
  • Regulatory compliance
  • Microbiological testing
  • Team training
  • Technical documentation
  • Data management
  • Document control
  • Positive attitude
  • Time management
  • Decision making
  • Technical troubleshooting
  • Effective communication
  • Ethics and integrity

Accomplishments

  • Received Award for best Sr. Research Associate of Microbiology Department at Accuprec Research Labs. Pvt. Ltd.
  • Secured 2nd position in B.Sc. Microbiology at Sardar Patel University May-2010.
  • Qualified GATE 2013 with 92 percentile.

Degree

M.Sc. MICROBIOLOGY

Research Publications

  • Joshi MN, Dhebar SV, Dhebar SV, Bhargava P, Pandit A, Patel RP, Saxena AK, Bagatharia SB, Metagenomics of petroleum muck: revealing microbial diversity and depicting microbial syntrophy., Archives of Microbiology, 08/01/14, 196, 8, 531-44, 10.1007/s00203-014-0992-0
  • Joshi MN, Dhebar SV, Dhebar SV, Bhargava P, Pandit A, Patel RP, Saxena AK, Bagatharia SB, Metagenomic approach for understanding microbial population from petroleum sample., Genome Announcement, 2, 3, 10.1128/genomeA.00533-14

Timeline

Senior Research Associate

Accuprec Research Lab
12.2023 - Current

Executive

Emcure pharmaceuticals Limited
07.2018 - 11.2022

Senior Microbiologist

Concord Biotech Limited
01.2017 - 06.2018

Senior Research Fellow (SRF) in MicroExcon Project

Gujarat State Biotechnology Mission (GSBTM)
06.2014 - 01.2017

Junior Research Fellow (JRF) in MicroExcon Project

Gujarat State Biotechnology Mission (GSBTM)
08.2012 - 06.2014

Master of Science - Microbiology

The Maharaja Sayajirao University of Baroda

Bachelor of Science - Microbiology

Natubhai. V. Patel College of Pure and Applied Sciences (NVPAS)
SHIVANGI DHEBAR