Kailas Ingle Mvsc
Senior Toxicologist (Global Nonclinical Drug Development and Safety Assessment) @Elanco
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WORK HISTORY
Senior Toxicologist (Global Nonclinical Drug Development and Safety Assessment) @Elanco
Working as a lead for supporting Global Nonclinical Drug Development and Safety Assessment• Worked as Subject Matter Specialist for supporting early drug discovery activities for screening of drug candidates/lead selection/lead optimization across Elanco research activities.• Leading the Center of Excellence (CoE) working group for determining HBEL limits and extractable /leachable safety assessment.• Generating toxicological risk assessment reports for extractable & leachable associated with container closure system (CCS) of drug products & manufacturing components using ISO, PQRI/ELSIE guidance.• Conducting genotoxicity assessment of impurities or chemicals using in-silico tools and QSAR approaches and product specific assessments.• Experienced in using various in silico QSAR tools, including Derek-Sarah Nexus, Leadscope, Toxtree, and the OECD QSAR Toolbox, to support safety risk assessment and early screening of drug candidates.• Determine Health-Based Exposure Limit (PDE/OEL) monographs for pharmaceutical drug substances, excipients, and impurities.• Performing product safety assessment for manufacturing deviations.• Drafting pathology report and peer review of hisopatholoy slides from Target Animal Safety Studies • Responsible for designing, planning, and direct management and monitoring of toxicology studies (in vivo/in vitro) needed for drug discovery/development projects at various domestic and international CROs.
EDUCATION
Mahrashtra Animal and Fishary Science Nagpur
M.V.Sc.
ABOUT KAILAS INGLE MVSC
American board-certified toxicologist (DABT) and Indian board-certified toxicopathologist…
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