Berny Mullappally Email Address

Global Regulatory Strategy at Oncology Business Group, Eisai Inc

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Professional biochemical Engineer with broad experience in bio-pharmacetical industry and academic research.Review and compiling of regulatory documents such as Investigational New Drug Application (IND), Biologics License Application (BLA), comparability studies and method qualifications etc.Authored technical reports and CMC sections for regulatory documents.Develops novel LC/MS based methods and analytical methods for protein primary structural analysis, aminoacid analysis, peptide/protein sequencing, peptide mapping, disulfide linkage determination, glycan profiling and post-translational modifications etc.Maintain current knowledge of the FDA regulations and compliance activities through job related training.Leadership and project management experience from leading multiple-cross site and cross functional teams on critical projects successfully and in a timely manner.Experience in process improvements and technology transfers.Developed an excellent knowledge and understanding of current Good Manufacturing Practices (cGMPs), Safety and environment compliance policies. Analyst in process development team, executing protein purification and characterizing monoclonal antibodiesWorking on multiple platforms of protein characterization ,protein purification, Chemical engineering, molecular biology, immunofluorescence, imaging and cell culturing. Drafting SOPs for operation of lab equipments.Team player, self-motivated and data managementSpecialties: LC/MS Method Development/Validation/Transfer, Drug formulation,Process optimzation,Protein Characterization, Mass spectrometry, Glycan Structural Charecterization, Proteomics, CMC regulatory affairs, chemical engineering, process development, analytical chemistry