Shamik Sharma
Senior Director, Process Development @Voyager Therapeutics, Inc
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WORK HISTORY
Senior Director, Process Development @Voyager Therapeutics, Inc
Lead Process Development Team within Technical Operations, responsible for development of cell line, plasmids, upstream process and downstream process for the manufacture of engineered AAV vectors- Collaborate with research team to assess and address manufacturability of candidates to facilitate portfolio entry- Provide oversight on external process development activities and GMP manufacturing for AAV/mAb programs - Directed the transition to a mammalian-cell based transfection platform for AAV production from legacy infection based platform; built team, and managed development of expression system as well as manufacturing process utilized for clinical manufacturing- Support regulatory filings through authoring /review of document sections and query responses for AAV and antibody programs; provide feedback on knowledge management strategy and specifications
EDUCATION
Savitribai Phule Pune University
B.E., Chemical Engineering
New Mexico State University
Transferred, Chemical Engineering
Clemson University
Ph.D., Chemical Engineering
SKILLS
ABOUT SHAMIK SHARMA
Process development team leader with extensive experience combining drug substance development and project management expertise to help advance programs through clinical development - including AAV gene therapy, monoclonal antibodies, bispecific antibodies, antibody drug conjugates and vaccines.
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