Research And Development Scientist
CurrentExperienced Research & Development and Regulatory Professional with over 5 years of expertise in the medical devices and stem cell-based therapeutic products. Proficient in independently handling the processing, characterization, and differentiation of adult and tissue-specific human mesenchymal stem cells (MSC), specifically derived from clinical-grade bone marrow, both in 2D cultures and within tissue-engineered scaffolds/hydrogels.Possessing 2 International Patents and a portfolio of… Show more Experienced Research & Development and Regulatory Professional with over 5 years of expertise in the medical devices and stem cell-based therapeutic products. Proficient in independently handling the processing, characterization, and differentiation of adult and tissue-specific human mesenchymal stem cells (MSC), specifically derived from clinical-grade bone marrow, both in 2D cultures and within tissue-engineered scaffolds/hydrogels.Possessing 2 International Patents and a portfolio of publications in esteemed international journals, my current focus involves pioneering work on an artificial skin substitute—a cutting-edge stem cell-impregnated scaffold designed for diabetic foot ulcers and venous leg ulcers. My role extends to overseeing the clinical trial for this innovative product as a Clinical Trial Monitoring Scientist at three sites in India.Apart from designing experiments in compliance with OECD/GLP and ISO guidelines, I play an integral role in the preparation and review of regulatory documents compliant with EU-MDR and USFDA. My dedication to advancing medical research is evident in both my practical contributions and my commitment to ensuring all processes adhere to the highest industry standards.ISO 13485| EU MDR 2017|ISO 17025| EUDAMEDTwo major projects that i worked upon are -a) "Differentiation of MSC's into insulin producing pancreatic islet cells" - Successfully developed pancreatic islet cells for which pre-clinical studies are ongoing.b) "Fabrication of novel biodegradable and biocompatible nerve guidance conduits for peripheral nerve injury"I have a strong background in project management and team collaboration, working with cross-functional teams to ensure that projects meet regulatory and safety standards. Show less