● Execution of Immunoassay Method Development, Method Validation and Study Sample Analysis from human clinical trial samples for the estimation ofantibodies in biological matrices for various immunogenisity projects using various immunoanalytical techniques like ELISA etc● Method Development, Method Validation and Study sample analysis for Immunogenisity/PK/PD assessment using Ligand Binding Assays, Conducting Experiments, Documentation and Compilation of data.● Handle multiple projects, coordination with team members to ensure smoothexecution of activities.● Responsible for execution of immunoassays, PK/PD assays and promptly record data in appropriate documents.● Responsible for communication of experimental results from time to time to the supervisor.● Ensure that all instruments inside the laboratory are maintained as per the schedule and calibrated on time.● Preparation of SOPs, Formats, Validation Plan, Study Plan, Method Development Report, Validation Report and Study Reports etc. based on therequirement for every project.● Perform the activities inside the laboratory in compliance with GLP/GCLP and approved SOPs.● Follow appropriate safety practices and any other responsibilities as assigned by the supervisor.

● As Scientist II, my responsibilities were to spearhead multiple projects in coordination with the team and ensure the smooth execution of activities about Immunogenicity and LC-MS.● During this tenure, roles required me to manage the development, transfer, validation and technical leadership in issue resolution of specific and sensitive bioanalytical methods required for the development of compound (drug), anti-drug antibodies (ADA), soluble targets and biomarkers, metabolites and any concomitant/interaction compound in the project. ● Formulated SOPs for Immunogenicity projects, steered laboratory activities in compliance with GLP/GCLP and approved SOPs.● As Project In-charge, I performed ADA Full Method Validation and Study Sample Analysis for Insulin-Glargine using bridging ELISA format.

● While working as a Research Development Executive, I displayed skills in ELISA, Method Development, Method Validation and Study sample analysis for large molecules by adhering to the SOPs in compliance with GLP/GCLP procedures.● Besides, I managed Method Development and Quantification of Antigen in various drug products. Conducted qualitative analysis of Sera Samples of Laboratory Animals.● Executed Immunoassay Method Development, Method Validation and Study Sample Analysis from human clinical trial samples for the estimation of antibodies in biological matrices for various vaccine projects using various immunoanalytical techniques like ELISA, etc.● Over my tenure, I developed an in-house method for the estimation of polysaccharides PSaA (Pneumococcal Surface Adhesion Antigen) and CRM (Cross Reacting Material) for the formulation of Pneumococcal Conjugate Vaccine in Drug Substance and Drug Product using ELISA. ● Performed partial validation followed by study sample analysis for newly developed Paediatric Pneumococcal Conjugate Vaccine 14-Valent (Received DCGI’s nod for manufacture of 14-valent paediatric Pneumococcal Conjugate Vaccine) and 23-valent.● Created SOPs, LCRs, GCRs, analytical plans, analytical reports, etc. based on the requirement. Drove activities in the clinical serology laboratory in compliance with GCLP and approved SOPs.I also mentored the team to ensure the smooth execution of activities about immunology and clinical serology.

Throughout, acquired expertise in Bio-assays (ELISA-based), method development, method validation and sample analysis, experimentation, and documentation/data compilation, and executed the laboratory tasks assigned by the project lead.• Method Development, Method Validation and Sample Analysis for Immunogenicity and Pharmacokinetics Assessment using Ligand Binding Assays.• Operations, Maintenance, Calibration and Verification of Analytical Instruments, ULT Freezers, Plate Washers, Electronic Pipettes, Incubators, Plate Washers, etc.• Adhered to instructions given in the study plan, MOA & SOP.• Prepared buffers and reagents.• Followed Good Laboratory Practices.

Magnetic separation and enumeration of sepsis causing bacteria using synthetic ligand coated iron oxide nanoparticles.