Kapil Kothary
Director - Global Manufacturing Sciences and Technology (Msat) @CSL
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WORK HISTORY
Director - Global Manufacturing Sciences and Technology (Msat) @CSL
King of Prussia, PA, US
EDUCATION
University of Massachusetts Lowell
MS, Chemical Engineering and Biotechnology
University of Mumbai
BS, Chemical Engineering
Regulatory Affairs Professional Society (RAPS)
Regulatory Affairs Certificate, Biopharmaceuticals
ABOUT KAPIL KOTHARY
Biopharmaceutical manufacturing leader with extensive experience across advanced biologics platforms including gene therapies, viral vectors, monoclonal antibodies, vaccines, and plasma-derived products. Extensive expertise spanning the full product lifecycle from process development and characterization through commercial manufacturing and lifecycle optimization.Deep technical experience in upstream and downstream bioprocessing, including scale-up and scale-down model development, process characterization and QbD design space establishment, late-stage process optimization, and technology transfer to internal manufacturing sites and global CDMOs. Experienced in supporting CMC strategy, IND/BLA submissions, process validation, and commercialization of complex biologics manufacturing processes.Recognized for leading cross-functional teams to resolve complex manufacturing challenges involving process robustness, product quality attributes, potency, and scalability, while supporting regulatory interactions with global health authorities.In addition to core bioprocess expertise, strong interest in advancing data-driven and digitally enabled biologics manufacturing through the use of statistical analysis, data visualization, and modern analytical tools. Advocate for the adoption of digital dashboards, statistical modeling, and emerging AI-assisted analytics to improve manufacturing investigations, process understanding, and operational decision-making.Passionate about operating at the intersection of biology, engineering, data science, and regulatory strategy to build robust manufacturing platforms capable of supporting global commercial supply of advanced biologic therapies.Areas of Expertise • Advanced Biologics Manufacturing • Gene Therapy & Viral Vector Production • Monoclonal Antibody Manufacturing • Process Characterization & QbD • Upstream & Downstream Bioprocessing • Technology Transfer & CDMO Management • Process Scale-Up & Commercialization • CMC Strategy & Regulatory Submissions • Data-Driven Manufacturing & Digital Analytics
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