Manesh Shah
About Manesh Shah
Manesh Shah is a Sr. Specialist in Quality Assurance Operations for Cell Therapy at Bristol Myers Squibb in Summit, New Jersey, with extensive experience in analytical method development and validation.
Title and Current Positions
Manesh Shah holds the title of Sr. Specialist, Quality Assurance Operations in Cell Therapy at Bristol Myers Squibb. He is based in Summit, New Jersey. Additionally, he operates as a Quality Assurance Specialist in CAR-T- Cell Therapy Development Operations at Bristol Myers Squibb. His roles involve ensuring the quality and compliance of cell therapy products, likely contributing to the advancement of cutting-edge cell therapy treatments.
Professional Experience
Manesh Shah's career spans several notable positions in the pharmaceutical industry. He has worked as a Sr. Scientist in Global Quality Operations at Eurofins PSS Insourcing Solutions (Celgene Inc.). At Celgene, he has also served as Sr. Scientist in Global Quality Improvement and as an analyst. His extensive experience extends to Catalent, where he held a Scientist position for 15 years. Earlier in his career, he worked at IVAX for three years, Wyeth Pharmaceuticals for three years, and Biocraft Laboratories for seven years. These roles have imbued him with significant expertise in quality assurance and scientific research.
Educational Background
Manesh Shah studied Chemistry at S.P. University in India. He completed his Bachelor's degree over four years from 1977 to 1981. This solid educational foundation in chemistry has underpinned his extensive career in the pharmaceutical industry, allowing him to excel particularly in analytical method development and quality assurance.
Expertise in Analytical Method Development
Manesh Shah possesses advanced technical knowledge in analytical method development and validation. He has successfully developed and validated stability indicating methods utilizing both HPLC and UPLC. His expertise extends to authoring protocols and reports related to analytical method development and validation. Additionally, he has supported formulation, chemical development, stability studies, and routine testing, including release testing, freeze-thaw studies, and post-packaging analysis.
Regulatory Compliance Experience
Throughout his career, Manesh Shah has amassed experience with USP, EP, ICH, and FDA regulations. This familiarity with key regulatory frameworks is crucial for ensuring the compliance and quality of pharmaceutical products. His role in quality assurance operations likely involves regular interaction with these regulations to maintain high standards across all facets of his work.