Nirmal Paliwal
Director - Cmc, Analytical and Formulation Development @Icosavax, Inc
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WORK HISTORY
Director - Cmc, Analytical and Formulation Development @Icosavax, Inc
CMC Development of Virus-Like Particle (VLP) technology-based vaccines against various infectious diseases, with multiple self-assembling protein components as well as adjuvants. • As a CMC team member collaborate across all disciplines within the company as well as manage external vendors/CDMO\'s/CTL\'s to progress early and late-stage CMC development. • Technical review and approval of internal and external CMC and analytical documentation. • Upstream (CHO and E Coli.), Downstream (CHO and E Coli.) and Analytical technology transfer for scale up establishment, qualification, and validation for DSI, DS and DP (Biologics) • CMC platform development and delivery of GMP clinical trial and toxicology material in a time and cost-effective manner. • Process optimization and troubleshooting of analytical methods at CDMO’s & CRO’s, delivery of CMC sections for CTD documents. • Make critical decisions and trade-offs that improve resource utilization and ensure program success while maintaining phase appropriate risk profile.
EDUCATION
University of Massachusetts Lowell
Doctor of Philosophy (Ph.D.), Biochemistry
University of Massachusetts Lowell
M.S., Biotechnology and Biomedical Engineering
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