Deputy Manager-Dmpk & Toxicology
Anthem Biosciences Private Limited
Highly skilled scientist with more than 6 years working in Preclinical research laboratory (GLP), excellent writing, oral communication, organizational and analytical capabilities.Successfully managed over 2500 Non-GLP studies supporting Drug metabolism and pharmacokinetics (DMPK) assessment in the development of novel drug candidates.Successfully managed over 35 GLP studies supporting Preclinical Genetic toxicology safety assessment in the development of novel drug candidates and nutraceuticals.Protocol development, Study design development and Report writing for GLP and Non-GLP studies.Conducts discussion with clients on their Investigational New Drug (IND) enabling studies.Thorough knowledge of OECD, ICH, and EPA test guidelines, FDA-GLP and IAEC.Provides leadership and training to new Study Directors, Study Personnel’s and Study Coordination staff. Participates in the peer-review process of protocols, reports, and SOP's.Planed, designed, and executed advanced lab experiments utilizing molecular biology and cell culture techniques (CHO-K1, L5178YTK+/-3.7.2C, BALB/c 3T3, Caco2, hERG-CHO, HepG2 cell lines and Hepatocytes). Extensive research experience of working on in vitro Chromosomal aberration, micronucleus, mouse lymphoma assay, 3T3 Neutral Red Phototoxicity test, in vitro skin irritation/ corrosion tests and Physicochemical properties testing.Working knowledge of Bioanalytical sample extraction techniques, Molecular Biology research techniques like Flow Cytometry and ELISA.