Arnik Shah
Scientist @Visterra Inc.
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WORK HISTORY
Scientist @Visterra Inc.
Waltham, MA, US
EDUCATION
Northeastern University
Master of Science (M.S.), Biopharmaceutucal Regulatory Science
Northeastern University
Doctor of Philosophy - PhD, Analytical Science
SKILLS
ABOUT ARNIK SHAH
Analytical Scientist with experience in characterization of biologics utilizing various LC-MS based approach. Skilled in analytical method development, qualification, and transfer for different protein modalities. Proficient in executing forced-degradation and stability studies, product and process characterization, and qualifications of comparability and reference standards.Successfully conducted product characterization for diverse biotherapeutic modalities such as monoclonal antibodies, Bi-specific T-cell engagers, fusion proteins, and enzyme replacement therapies. Authored technical documents including method development and qualification reports, contributing to three approved biologics in the US market through sections of BLA (biologic licensing application). Outstanding analytical and problem-solving skills with a proven ability to collaborate effectively with cross-functional teams, including regulatory teams, to provide responses to FDA inquiries.
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