More than a decade experience in developing Biosimilar mAbs, Insulin/Insulin analogs, Peptides and Complex Injectable (Novel Drug Delivery System and 505(b)(2) formulation) for regulated market (US, EU, AUS). Strong scientific background in methods development, validation and Biosimilar characterization including comparability assessment. Highly skilled to implement knowledge & technology, functional understanding of GLP/GCP/GMP and a strong understanding of ICH Quality and USP regulations. Trained and experience in advanced techniques in Cell line engineering, Bioassays, Bioanalytical Sciences PK, TK (nonclinical and clinical) and Immunogenicity assessment for Biosimilar and Complex Injectable.