arnaud rager
vice president, r and d strategy and operations at sangamo therapeutics, inc.
biotechnology, operations
orinda, california, united states
Sandeep Yadav
CMC Strategy
About
• Technical and strategic expertise in DS/DP processes, formulation & analytical development for biologics & CGTs including manufacturing operations and tech transfer to internal/CMO facilities.
• Track record of successfully leading product strategy: clinical CMC strategy through PPQ and licensure as well as managing commercial product strategy & lifecycle management
• Experience with insourcing and outsourcing projects including vendor due diligence, supplier qualification, strategic collaboration/contract negotiations with CMO/CDMOs.
• Proficient with global regulatory requirements, health agency interactions (Pre-IND through Type C/D etc.) and module 3 CTD authoring/review experience across global regulatory agencies (IND/CTA/BLA/MAA etc.)
• Actively engaged with scientific community at large with ~30 publications in peer reviewed journals, industry collaborations/presentations and organizing symposia at leading scientific conferences in the field.
• Successful track record and passion for leading teams and people management driving functional engagement and enterprise success.
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Local Location
South San Francisco, California, United States
Industry
Pharmaceutical Manufacturing
Designation
CMC Strategy
Birthday
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