Stephane Calmat
About Stephane Calmat
Stephane Calmat is the Director of CMC Development Strategy at Inozyme Pharma, where he has worked since 2024. He holds a PhD in Biochemistry and Biophysics from Vrije Universiteit Amsterdam and has extensive experience in analytical development, quality control, and regulatory requirements across various regions.
Work at Inozyme
Stephane Calmat currently holds the position of Director - CMC Development Strategy at Inozyme Pharma, a role he has occupied since 2024. In this capacity, he focuses on the strategic development of Chemistry, Manufacturing, and Controls (CMC) processes. His responsibilities include overseeing the development of regulatory strategies and ensuring compliance with industry standards.
Education and Expertise
Stephane Calmat has an extensive educational background in biochemistry and microbiology. He earned a Bachelor of Science in Biochemistry from Université Paris Cité in 2002, followed by a Master of Science in Microbiology from the same institution in 2003. He completed his PhD in Biochemistry and Biophysics at Vrije Universiteit Amsterdam from 2004 to 2009. His academic training provides a strong foundation for his expertise in CMC development and regulatory compliance.
Background
Prior to his current role, Stephane Calmat worked at SQZ Biotechnologies in various capacities, including Associate Director of Analytical Development and Director of Analytical Development & Quality Control. He also served as a Research Specialist at the Howard Hughes Medical Institute at MIT. His experience spans multiple aspects of CMC development, particularly in cell therapy products.
Achievements
Throughout his career, Stephane Calmat has developed a strong background in regulatory requirements across the US, Canada, Europe, and Asia. He has successfully managed relationships with Contract Development and Manufacturing Organizations (CDMO), Contract Research Organizations (CRO), and Clinical Trial Laboratories (CTL). His experience includes establishing GMP quality control testing labs and overseeing technology transfer processes in cell therapy.
Technical Skills
Stephane Calmat possesses a range of technical skills relevant to CMC development. He is experienced in early-phase CMC study design and execution, technical writing, and managing quality events within the framework of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance. His expertise also includes budget setting and program management, which are critical for successful project execution in the biopharmaceutical industry.