Professional Summary: 12+ years of diversified research experience in discovery and development of novel therapeutic molecules and biosimilars (monoclonal antibodies, fusion peptides, recombinant proteins, non steroidal anti-inflammatory drugs, hormones and low molecular weight heparin) from bench to bedside for the treatment of cancer and autoimmune diseases under regulated environment. * Oversee scientific operations and the administrative and budgetary affairs of a highly specialized research service group. * Manage therapeutic or project teams to align activity to meet the organizational objectives of the business. * Communicate and present findings and outcomes of research to enable go/no go decisions on projects. * Directs and oversees multiple research projects from research design to implementation, analysis and product development. * Strong research interest in immunology and oncology translational studies. * Experienced and well qualified onco-immunologist with versatile skill set. * Experienced in leading, managing and planning of scientific projects and laboratory set up as per GLP compliance, proof of concept and mode of action studies, collaborating with cross- functional teams and other organizations, technology transfer, quality system set up. * Excellent manager, trainer, team member, well-read of current research topics, quick learner, independent thinker, analyzer and problem solver. * Efficient in managing multiple projects at a given timewith expertise in the design as well as deadline-centric execution of research projects aimed at therapeutic endpoints. * Highly motivated with a drive to excel in all my endeavors, with excellent communication, presentation and organization skills. * Excellent know-how of various aspects of translational medicine to facilitates the bench to bedside transition and regulatory guidelines set by FDA, EMEA, ANVISA and ICH. Worked for discovery and development of molecules like - Alzumab (anti CD6), Fusion proteins, therapeutic vaccines for solid tumors and cervical cancer, anti EGFR monoclonal antibodies, Glatiramer acetate, Rituximab, Etanercept, Adalimumab, Trastuzumab, Bevacizumab, granulocyte colony stimulating factor (GCSF), non steroidal anti inflammatory drugs, low molecular weight heparin (LMWH), human growth hormone (HGH), anti CD25, anti CD4, anti CD8 monoclonal antibodies. Key Technical Strengths: * Immunological techniques for T, B, NK, dendritic cells functions and signaling. * Proliferation assays, cytotoxicity assays, flow cytometry, immune phenotyping, magnetic cell sorting, molecular cell signaling assays, immune cells cross talks. Cell line maintenance and characterization. * Development and validationof cell based assays, potency assays, in-vitro, ex- vivo and in-vivo bioassays, reporter gene assays as per bioassay guidelines byFDA. * Development and validation of antibody dependent cell cytotoxicity (ADCC) assays, Complement dependent cytotoxicity (CDC) assay. * Development and validationof ELISA based PK/PD assays as per FDA/ANVISA/EMEA guidelines for regulatory submission (Sandwich, Bridging, Direct/Indirect ELISA). * Development and validation of immunogenicity assays, anti-drug antibody assay (ADA), neutralizing antibody (Nab) assays (screening and confirmatory) as per FDA guidelines. * Immunization studies, antibody purification, reagent validation/stability studies, quality control method development and qualifications. * Surface plasmon resonance based affinity/ binding studies for antigen antibody pairs. * Knowledge of various tools used for data analysis, such as JMP, Graph pad Prism, PLA, SPSS, Summit, Cell Quest. * System set up for quality assessment, QA documentations, SOP preparation and reviewing. of 5 * Establishing murine models, optimization of experimental conditions (in-vivo, ex-vivo and in - vitro), understanding mechanism of action using in-vivo/ex-vivo/in-vitro experimentations. * In vivo efficacy studies for vaccines, molecules for treatment of multiple sclerosis (EAE models), and arthritis. * Leading planning and execution of preclinical and clinical studies as per regulatory requirements for novel molecules and biosimilars.

Highlights:

• Bioassay development
• development and qualification
• validation
• immunology
• cell based assay
• pharmacokinetic and pharmacodynamic
• ELISA
• IMMUNOGENICITY AND NEUTRALIZING ASSAY
• Management
• Transcription
• Cancer
• Documentation
• Pathway
• Planning
• Procurement
• Quality
• Drug discovery and development
• Biologics
• Immunotherapy
• Drug discovery