Pratima Sinha
Director, Cell Therapy Process Development @Immunomic Therapeutics, Inc
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WORK HISTORY
Director, Cell Therapy Process Development @Immunomic Therapeutics, Inc
Rockville, MD, US
Accountable for automated and closed cGMP cell therapy process development for clinical manufacturing• Lead in release criteria and potency assay development for cell therapy product• Manage budget for the division in alignment with the organization• Drive continuous improvement opportunities in each unit operation during process development• Build and recruit CTPD as per need of the organization• Collaborate with Process development, Quality, and Regulatory groups in cGMP process development activities for commercial manufacturing
EDUCATION
Banaras Hindu University
Master of Science (M.Sc.)
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Doctor of Philosophy (Ph.D.), Biomedical Sciences
Banaras Hindu University
Bachelor of Science (B.Sc.)
ABOUT PRATIMA SINHA
I was the first member to join Immuno-oncology at Immunomic Therapeutics, Inc, and was therefore able to build this program from the ground up. With over 15 years of experience in cancer research and immuno-oncology, I lead a team of scientists in developing and optimizing novel cell and gene therapy processes for clinical and commercial manufacturing. My core competencies include CMC, analytical development, quality and regulatory requirements, potency assay development, release criteria, tech transfer, and CDMO selection and management. I have successfully transitioned a manual cell therapy process to an automated and closed system, using various platforms and technologies. I have also developed and qualified potency assays and analytics for the cell therapy product, and collaborated with internal and external partners in the process development, preclinical, and clinical development of cell and gene therapies. I am passionate about using my expertise and professional training to contribute to the development of cutting-edge therapies for human diseases.
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