Pankaj (Pat) Patel
About Pankaj (Pat) Patel
Pankaj (Pat) Patel is a Senior Manager in Process Analytics and Quality Control at Evelo Biosciences, with extensive experience in quality management across various pharmaceutical companies. He has a strong background in quality control testing, method validation, and compliance with regulatory standards.
Work at Evelo Biosciences
Pankaj Patel currently serves as the Senior Manager of Process Analytics and Quality Control at Evelo Biosciences, a position he has held since 2021. In this role, he oversees the quality control processes and analytics for the company's operations in Cambridge, Massachusetts. His responsibilities include managing quality control testing and ensuring compliance with regulatory standards.
Previous Experience in Quality Control
Prior to his current role, Patel worked at several pharmaceutical companies. He was a Senior Quality Control Chemist at Norwich Pharma Services from 2006 to 2012, and later served as Quality Control Manager there from 2012 to 2015. He then took on the role of Quality Control Manager at Insys Therapeutics, Inc. from 2015 to 2019, followed by a position as Quality Assurance Manager and R&D Site Quality Head at Akorn, Inc. from 2019 to 2021.
Education and Expertise
Patel holds a Master of Science degree in Chemistry from The Maharaja Sayajirao University of Baroda, where he studied from 1992 to 1997. He also completed the Industrial Pharmaceutical Technology Program at Seneca College of Applied Arts and Technology in 2005. His education has provided him with a strong foundation in pharmaceutical sciences and quality control practices.
Achievements in Quality Control
Throughout his career, Patel has successfully managed quality control testing for various dosage forms, including solid, spray, and liquid. He has played a significant role in implementing quality systems compliant with 21CFR parts 11, 210, 211, 212, and 820. His experience includes managing the validation and transfer of analytical methods and authoring stability protocols.
Technical Skills and Methodologies
Patel has tested over 60 drug products using analytical techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Total Plate Count (TPW). He has also utilized Six Sigma lean methodologies, 5S, and visual lab management tools to improve the efficiency of operations within the Quality Control Laboratory.