Shruti Gadekar
Singapore
Summary
With over 9 years of experience in molecular biology techniques including PCR, RT-PCR, DNA extraction, electrophoresis, and DNA sequencing. Actively involved in developing RT-PCR Kits for the rapid detection of Covid-19 and its variants. Successfully established the HLA testing laboratory for the country's first Marrow Donor Registry, a registered charitable organization (NGO). Contributed as a Technical Reviewer to design and development documentation and served as an Internal Auditor13485. Completed a PG diploma in Clinical Research from Clariwell Global Services. Received comprehensive training in Clinical Trial Management, Trail Team coordination, basic documents preparation, and adherence to guidelines such as ICH, GCP, ICMR, CIOMS, CPCSEA. Training also included regulatory compliance, pharmacovigilance, scientific writing, clinical data management, and medical coding.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Scientific Officer B, Research and Development
Mylab Discovery Solutions
05.2021 - 04.2024
- RT PCR Kits developed – Covid Fast PCR, NAT (HBV, HCV and HIV), Mucor mycosis, Monsoon Fever Panel (Chicken Guinea, Dengue and Malaria), Covid Influenza, Respiratory PANEL, HPV High Risk Detection Kit (HPV 16,18. HPV 7High Risk target and HPA 14 High Risk target)
- Proposing novel and innovative product and its development process
- Literature search related to product development
- Validation and Verification of the products developed
- Lyophilization of PCR Reactions
- Nucleic Acid Extraction from different sample types and its Quantification
- Documentation of results and compilation of data, Data analysis/ interpretation
- Vendor Evaluation and Qualification
- Compliance with Quality Assurance plan
- Developed Algorithm and streamlined data analysis processes, resulting in more accurate findings and faster report generation.
- Worked for CDSCO approved kits
- Document preparation for Tech Transfer like SOP, Master Formula Record, Batch Manufacturing and Processing records, D&D, critical steps, TGW & TGR, stability protocol and other relevant documents
- Maintaining the lab documents as per ISO9001, ISO13485 & GMP Guidelines
- Reduced errors by standardizing laboratory procedures.
- Managed laboratory resources effectively for optimal utilization and to ensure timely delivery of results without compromising quality.
- Contributed to scientific community with published research papers.
- Assisted with regulatory compliance matters by maintaining detailed records of experiments and adhering to established guidelines.
- Train Juniors for Scientific equipment and processes and laboratory techniques to ensure compliance. Mentored junior scientists, enhancing their professional development and overall lab performance.
Research Officer, HLA Laboratory
Marrow Donor Registry India (MDRI), Mumbai
04.2010 - 11.2016
- DNA Extraction from Blood Samples and Cheek Swabs (manual method)
- Quantification of DNA by Qubit Fluorimeter
- HLA typing by SSOP using Autoreli - Probe hybridization and strip detection, Luminex - Bead based multiplexing, analyzing the result
- Resolving ambiguities observed in SSOP by repeat testing with manual SSP technique
- Uploading HLA typing data of recruited registry donors on the MDRI server
- Enabling HLA Matched donor searches for patients from the database of MDRI’s registered donors
- Analyzing the population data
- Ensured research compliance with ethical standards.
Product Executive
Krishgen Biosystem, India
10.2009 - 03.2010
- Providing technical support and troubleshooting
- Promotion of product and training the marketing team
- Handling commercial aspects
- Development of Elisa Kits
Education
Master of Science - Biotechnology
Mumbai University
05.2009
Bachelor of Science - Biotechnology
Pune University
05.2007
Skills
- Scientific research
- Data analysis
- Report writing
- Laboratory techniques
- Project management
- Technical documentation
- Quality Assurance and Regulatory compliance
- Quality control
- Data interpretation
- Team leadership
- Technical support and Experimental trouble shooting
- Clinical data management
Certification
- Completed Internal Auditor training on ISO13485:2016- Medical Devices Quality Management System.
- Completed Certificate course on ISO15189:2012 Medical Laboratories – Requirements for quality & competence and Internal Audit.
Publications and Presentations
- Leenam Dedhia, Shruti Gadekar, Pooja Mehta, Sunil Parekh. HLA haplotype diversity in the South Indian population and its relevance. Indian Journal of Transplantation.9(4);2015,138-143.
- Leenam Dedhia, Manasi Vijapukar-Valluri , Shruti Gadekar, Pooja Mehta, Sunil Parekh, Kanjaksha Ghosh. Distribution of HLA genes and disease predisposition in Bengali speaking people from India. Indian Journal of Transplantation.9 (1);2015,2-6.
- Minal Dakhale, Shruti Gadekar, Asmita Malekar, Gautam Wankhede. ‘Coviswift TM’: A point of care RT-PCR device for SARS-COV2 and its variant detection. Journal of Virological Methods,315(2023)1147141-8.
- Minal Dakhave, Amrita Khaire, Shruti Gadekar, Kamini Patil. Journal of Allergy and Infectious Diseases Load-and-go molecular diagnostics for human papilloma virus detection November 2024 Journal of Allergy & Infectious Diseases 5(1):56-61
- Minal Dakhale, Trupti Rale, Harshada Suryawanshi, Nikita Patil, Abhijeet Suryawanshi, Raju Kumar, Shruti Gadekar, Payal Bhatnagar, Amrita Khaire, Gautam Wankhede Advanced integrative molecular platform for high-throughput screening of drug-resistant tuberculosis. Journal Diagnostic Microbiology and infectious disease.
- Platform presentation in the2nd International Conference on Stem Cell and Cancer - ICSCC-2011, Pune, India. Title: “Marrow Donor Registry India – Strategies and Data”.
- Poster presentation in the17th congress of Asia-Pacific Blood and Marrow Transplantation Group. HLA Diversity in Indian Linguistic Groups – MDRI DATA. Hyderabad, India.
- Platform Presentation in the4th International Conference on Stem Cells and Cancer (ICSCC-2013): Proliferation, Differentiation and Apoptosis, Mumbai, India Title: “Marrow Donor Registry India Data- Unique Haplotypes in16 different Linguistic groups from India”.
- Platform Presentation in HAEMATOCON,54th annual conference of ISHBT (Indian Society of Hematology and Blood Transfusion)2013. Title: “Marrow Donor Registry India (MDRI) - Strategies and data”.
Timeline
Scientific Officer B, Research and Development
Mylab Discovery Solutions
05.2021 - 04.2024
Research Officer, HLA Laboratory
Marrow Donor Registry India (MDRI), Mumbai
04.2010 - 11.2016
Product Executive
Krishgen Biosystem, India
10.2009 - 03.2010
Bachelor of Science - Biotechnology
Pune University
Master of Science - Biotechnology
Mumbai University
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