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Fraser Leslie

Senior Vice President Tech Ops at Xilio Therapeutics

Fraser Leslie has extensive work experience in the biopharmaceutical industry, spanning over several companies and roles. Fraser began their career at the SNBTS Protein Fractionation Centre, where they worked as a Process Controller/Shift Manager and later as a Senior Development Scientist. In 1993, they became the Principal Regulatory Officer in the Quality Department, responsible for managing regulatory affairs and developing regulatory strategies for product development and licensing.

In 1998, Leslie joined PPL Therapeutics plc as the Head of Regulatory Affairs, overseeing all regulatory activities related to the development of recombinant biopharmaceuticals. Fraser then moved on to Viragen Ltd in 2001, where they served as the Director of Regulatory Affairs, responsible for regulatory affairs and quality oversight within the company.

Leslie joined the SNBTS Protein Fractionation Centre once again in 2005 as the Head of Quality, participating in the production, contract manufacturing, and out-licensing of plasma products. Fraser then transitioned to Valneva in 2006, where they held various roles, including Site Head and Head of Technical Operations, Deputy Site Director, Site Director Ad-Interim, and Head of Quality Operations and Global Head of Regulatory Compliance. During these roles, they managed quality, regulatory affairs, and compliance teams, ensuring EU and US cGMP requirements were met.

In 2013, Leslie became the Senior Vice President of Product Development at Arsanis, responsible for monoclonal antibody product development and overseeing CMC and GLP non-clinical programs. Fraser joined FLCMC Limited in 2019 as an Independent Technical Consultant, working on the post-merger transition with X4 Pharmaceuticals.

Leslie also held positions at Bravos Biosciences and currently works at Xilio Therapeutics, where they started as the Vice President of CMC in 2019 and now serves as the Senior Vice President of Tech Ops. In this role, they lead a team responsible for technical development, process and analytical development, manufacturing, CMC regulatory affairs, and GMP, focusing on developing immuno-oncology recombinant protein therapeutics.

Throughout their career, Leslie has demonstrated expertise in technical development, regulatory affairs, quality management, and compliance, contributing to the successful development and licensure of various biopharmaceutical products.

Fraser Leslie obtained their BSc (hons) degree in Biological Science, with a focus on Plant Biochemistry and Physiology, from the University of Stirling between 1981 and 1985. Fraser then pursued further education at the University of Strathclyde, where they earned a PGDip in Pharmaceutical Quality and GMP. The start and end years for this degree are not provided.

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Timeline

  • Senior Vice President Tech Ops

    December, 2021 - present

  • Vice President CMC

    December, 2019

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