Harish Gunda

 Development of patent non-infringing, Patentable bioequivalent generic and Differentiated formulations for regulated markets. Formulation development of immediate release/ modified release dosage forms for various regulated markets.  Formulation of New Product Development projects for Liquid and Solid Oral Potentials (Oral Solutions, Immediate & Extended-Release Tablets, Capsules, Compressed lozenge and Sachet Products).  Initiate Trail batch and Stability study of new products under development.  Responsible to present and compile results of research that has been conducted and to report all the results and findings to the R&D Manager.  Responsible to plan and conduct stability study for the Developmental products.  Ensure compliance to cGMP and GLP.  Prepare Registration Dossiers (Control Correspondence, Product development report, Biowaiver justification, and Comparative dissolution profiling and reference product characterization) for the stable formulations developed.  Sourcing and Material qualification of new raw material and packaging materials for developed product.  Participate in multi-disciplinary product development teams to provide manufacturing process input.  Conduct technology transfer from R&D to manufacturing facilities and between manufacturing facilities based on sound laboratory/pilot scale studies and thorough understanding of commercial scale processes.