eSupervisor Detail

About me

With a Master’s degree in Biotechnology, I offer a strong blend of scientific expertise, regulatory knowledge, and practical application aligned with the requirements of this role. In my current role as Research Scientist-II, I have developed extensive expertise in GLP-compliant study execution and a solid understanding of ISO 10993, ICH, OECD, ECHA and regulatory guidelines relevant to biocompatibility and toxicological risk assessment, led 200 biocompatibility evaluations for medical devices.

Interests: With a Master’s degree in Biotechnology and over a decade of experience spanning academic research and the CRO industry, I offer a strong blend of scientific expertise, regulatory knowledge, and practical application aligned with the requirements of this role. In my current role as Research Scientist-II, I have developed extensive expertise in GLP-compliant study execution and a solid understanding of ISO 10993, ICH, OECD, ECHA and regulatory guidelines relevant to biocompatibility and toxicological risk assessment. I have successfully led and overseen more than 200 biocompatibility evaluations for medical devices, including: Cytotoxicity assessments Genotoxicity studies Hemocompatibility testing Immunogenicity evaluations My experience includes end-to-end study management, data interpretation, and preparation of scientifically robust reports suitable for regulatory submission. Importantly, I have a strong track record in toxicological risk assessment and report preparation (~ 300 report - ADE/PDE, OEL/OEB, ERA, MDD, TRA), ensuring scientific accuracy, regulatory compliance, and clear communication of risk-based conclusions. Additionally, I bring strong expertise in cellular and tissue-based models, including isolation and characterization of mesenchymal stem cells, and the development of biomimetic hydrogels and scaffolds for tissue engineering applications. My hands-on experience with 3D bioprinting technologies further strengthens my ability to evaluate advanced biomaterials and device-tissue interactions. I also possess working knowledge of bioprocessing and analytical techniques, including filtration systems, chromatography, fermentation processes, and scale-up of adherent and suspension mammalian cell cultures using microcarrier technology. My prior experience at BIOZEEN India Ltd. has provided me with exposure to biopharmaceutical manufacturing operations, including sterilization practices (CIP/SIP).