Jeevan Ghosalkar Email & Phone Number

Mumbai, Maharashtra, India

Mumbai

More than eighteen years of experience across cadres with growing responsibilities from Research Scientist to Team Leader to Associate Director. Preclinical drug discovery scientist, with a broad scientific and therapeutic area expertise in Oncology, Autoimmune diseases, Pulmonary Hypertension and Viral diseases. During these years I have developed extensive scientific skills in establishing in vitro and in vivo assay platforms to ascertain efficacy, toxicity and PK/PD relations for wide range of drugs from peptides, small molecules, complex biologics to monoclonal antibodies. I am also a member of Cipla Discovery Engine team for all 505 b2 projects like discovering novel drug combinations and drug repurposing. Trained extensively in protein expression studies at the University of Kentucky, under the guidance of Dr. Rangnekar (‎Associate Director, Markey Cancer Centre)Filed more than six provisional US patent applications which are due for complete filing this year. Listed as a co-author in four peer reviewed publications and two US patentsDuring the years in Cipla I also have gained vast knowledge about regulatory compliance. Proficiency in QA activities like generation of IOP/EOP/SOP/MOA, instrument / equipment qualification and generation of operational procedures

Mumbai

At Cipla IPD, I am Team leader for the Cell Biology lab. Cell Biology lab is the integral part of Cipla Biologics team involved in the development of Biosimilars/Generics. As a team leader I head a group of analysts involved in the development, standardization and validation different cell based assays like Cytotoxicity assay, Cell proliferation inhibition, ADCC, CDC, Cytokine profiling, cAMP assay, intracellular permeability, in vitro leakage, intracellular uptake studies, in-vitro PK studies. The assays are performed using different tools like ELISA, PAGE WB, Flow Cytometry, SPR. Under my leadership more then ten different types of assays for more than 50 molecules have been successfully completedI am responsible for maintaining GLP compliance by routine lab monitoring, preparing and implementing qualification and validation protocols, writing and reviewing SOPs / MOAs, documentation of work to meet regulatory standards. I am also a part of Cipla DE (Dicover Engine) team involved in drug repurposing activities. I have completed a project on drug repurposing in collaboration with Dr. Vivek Rangnekar at the Markey Cancer Centre, University of Kentucky to identify different Quinones and Quinolones having ability to induce PAR-4. PAR-4 is a Pro-Apoptotic protein involved in the apoptosis of cancer cells. During this project I have analyzed 100 different compounds out of which 5 have been identified as good inducers of PAR-4. These have been taken ahead to establish pre-clinical POC.I also am involved in Due Diligence for in licensing of different products.

Mumbai

Profile:• Handling chromatography equipments for protein purification in downstream processing • Designing of chromatography process and techniques• Application and process development in filtration for critical downstream and upstream applications• Analytical process development using innovative purification process techniques for faster and efficient process development• Handling and operating latest chromatography columns for purification right from laboratory scale system to pilot and to process scale systems (0.7cm diameter to 45cm diameter)• Handling analytical equipments and process like ELISA, HPLC, SDS-PAGE for purity/impurity profiling Projects handled:• Molecular weight estimation of small molecules (peptides) using state of the art Unicorn software• Development of chromatography purification step for Rabies vaccine right from project initiation to installation to process optimization• Development and optimization of microfiltration and ultrafiltration step using cross flow technique for microbial and yeast based products• Designing and optimization of different steps of protein purification using latest chromatography matrices for insulin purification• Closely associated with process development scientist for the purification of Biosimilars/Bio-Therapeutics• Imparting training to scientist at various organizations in pilot scale purification strategy

Executive Mba, Finance, Leadership & Strategy

Post Graduate Diploma In Regulatory Affairs (Api & Formulation), Regulatory Affairs

Doctor Of Philosophy (Ph.D.), Life Sciences

Ph.D

Master'S Degree, Microbiology

Master of Science (microbiology)