• Design, execution and data interpretation of pharmacokinetic, anti-drug antibody and neutralizing antibody assays to be transferred into the clinic• Oversee the transfer, implementation and application of clinical bioassays to CRO, or between CRO’s, for existing programs. Effectively communicate and interface with internal/external business partners including internal Compliance, Quality Assurance, and Regulatory functions to ensure that all study related materials are in compliance with Global Regulatory requirements• Represent clinical assay development on various project teams• Articulate and present scientific work at cross-functional group meetings. • Review study data on an on-going basis and prepare data summaries to be used in program updates and presentations

Develop and validate bioanalytical methods for quantitation of therapeutics and detection of anti-drug antibodies in matrixPerform Sample analysis in a regulated environment for pre-clinical toxicology studiesUse of various software like Watson, Softmax for data analysis ,storage, sample management Using Octet to screen antibodies and work on DOE for method development using JMPAuthor SOP for developed assays in compliance with the regulated standardsMaintain Electronic workbook for GLP record keepingWell versed with and practical application of GLP compliance during study support

Validation of immunogenicity assay for the determination of anti-drug antibodyValidation of Enzyme Activity Assay-Detection of antibodies that inhibit the recombinant human enzyme using the 4-Methyumblliferone conjugated substrateValidation of PK ELISA for the quantitation of enzyme in Human PlasmaData interpretation and documentation of the validated assays

Assay Development- ELISA development, optimization and validation for the quantification of the major capsid protein and minor capsid protein of the HPV16 virus like particleProtein Formulation - Development and Optimization of Disassembly & Reassembly of HPV16 virus like particles and loading with desired payload for therapeutic and diagnostic applicationsAnalytical characterization of the packaged DNA in the reassembled VLP using by agarose gel electrophoresisIsopycnic centrifugation for separating HPV16 virus like particlesCharacterization of the separated proteins using SDS-PAGE,BCA assay, Western blot and BSA Gel quantification

Assay Development- ELISA development, optimization and validation for the quantification of the major capsid protein and minor capsid protein of the HPV16 virus like particleProtein Formulation - Development and Optimization of Disassembly & Reassembly of HPV16 virus like particles and loading with desired payload for therapeutic and diagnostic applicationsAnalytical characterization of the packaged DNA in the reassembled VLP using by agarose gel electrophoresisIsopycnic centrifugation for separating HPV16 virus like particlesCharacterization of the separated proteins using SDS-PAGE,BCA assay, Western blot and BSA Gel quantification

Research student at Center for Pharmaceutical Biotechnology and Nanomedicine