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The Team

Who We Are

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Founder 

I’m an accomplished biopharmaceutical manufacturing leader with over two decades of hands-on experience in product lifecycle management (Process Development & Characterization, Scale-Up & Tech Transfer, PPQ and CPV). My expertise has been shaped by leadership roles at globally recognized pharmaceutical organizations including Lonza, AstraZeneca, Thermo Fisher Scientific, Novartis, and Boehringer Ingelheim.

(314) 496 8483

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Advisory Board Member 

Dr. Nilesh Shah serves as an Advisory Board Member at Bench2Batch™, bringing more than 35 years of experience across the biopharmaceutical, life sciences, and healthcare technology sectors. Throughout his career, he has held leadership and technical roles within globally recognized organizations including Gritstone bio, Five Prime, Medivation, GSK, Seattle Genetics, and ICOS, where he contributed to advancing complex biologics and life-science technologies.

 

Dr. Shah has extensive expertise in CMC strategy, bioprocess development, technology transfer, and manufacturing readiness for biologics and emerging therapeutic modalities. His work has supported programs spanning early development through clinical manufacturing and commercialization, with particular experience in viral vector platforms, mRNA, and monoclonal antibodies, and life-science technology integration. In addition to his technical background, he brings strong experience in global operations, cross-functional leadership, and strategic program execution, helping organizations align scientific innovation with scalable manufacturing and business objectives.

 

At Bench2Batch™, Dr. Shah provides strategic guidance on biopharmaceutical development, technology transfer, manufacturing strategy, and process validation, supporting the company’s mission to deliver practical, science-driven solutions that bridge the gap between research innovation and manufacturing execution.

His perspective strengthens Bench2Batch’s ability to support biotechnology companies in translating complex scientific programs into robust, manufacturable processes for early clinical trials to commercialization.

(484) 535-0723

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Scientific Advisory Board Member 

Dr. Nagarjun Kasaraneni is an accomplished scientist with extensive expertise in analytical development, gene therapy, and protein characterization. With over seven years of industry experience at leading biotech companies, including Sana Biotechnology and Editas Medicine, he has played a pivotal role in advancing cell and gene therapies from discovery through clinical development.

Dr. Kasaraneni specializes in analytical method development, process technology transfer, and regulatory strategy, with a focus on Viral Vectors, Lipid Nanoparticles (LNPs), Antibody-Drug Conjugates (ADCs), and in-vivo CAR-T/gene editing platforms. His work has contributed to the successful characterization and optimization of novel biologics, ensuring their robustness, scalability, and regulatory compliance.

In addition to his technical expertise, Dr. Kasaraneni has been actively involved in mentoring and cross-functional collaborations, bridging the gap between research, manufacturing, and regulatory functions. His deep understanding of cGMP guidelines, process validation, and assay qualification has made him a key contributor to IND-enabling studies and commercialization efforts in cutting-edge therapeutics.

At Bench2Batch™, LLC, he serves as a Scientific Advisory Board Member, providing strategic insight on emerging technologies in cell and gene therapy, vector engineering, and advanced biologics development.

(123) 456-7890

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