Salim M.
About Salim M.
Salim M. is a Senior Director of Validation with over 15 years of experience in process engineering and validation, specializing in vaccine and cell therapy manufacturing. He has held leadership roles at various pharmaceutical companies, including Dendreon, Kite Pharma, and Instil Bio.
Current Role at Instil Bio
Currently, Salim M. serves as the Senior Director of Validation at Instil Bio, a position he has held since 2021. In this role, he leads qualification efforts for facilities, equipment, and enterprise systems. His responsibilities include ensuring compliance with regulatory standards and overseeing validation processes critical to the company's operations in the biotechnology sector.
Previous Experience in Validation and Quality Engineering
Salim M. has extensive experience in validation and quality engineering across several prominent organizations. He worked at Kite Pharma, Inc. as Senior Director of Validation from 2017 to 2021 and held the same title at Dendreon from 2012 to 2013. His roles included managing quality validation processes and ensuring adherence to industry regulations. Additionally, he served as Associate Director of Process Engineering at Pfizer from 2008 to 2011, where he focused on process validation.
Education and Expertise in Engineering
Salim M. holds a Master of Science in Physiology from the University of Toronto, which he completed from 1995 to 1998. He also earned a Bachelor of Engineering in Chemical Engineering from McGill University between 1990 and 1994. His educational background supports his expertise in process engineering and validation, particularly in vaccine and cell therapy manufacturing.
Specialization in Validation Processes
Salim M. specializes in handling consent decrees and post-marketing development. He possesses expertise in transportation validation and shipper qualification. His focus on chain of identity and chain of custody qualification ensures traceability in manufacturing processes, which is critical in the biotechnology field.
Career Timeline and Progression
Salim M.'s career spans over 15 years in process engineering and validation. He began as a Validation Engineer at Teva Canada from 1999 to 2000. He then progressed through various roles, including Associate Director at Pfizer and Director of Validation at Valeant Pharmaceuticals. His career reflects a steady advancement in responsibilities and expertise in the validation domain.