Director of Regulatory Affairs and QA, Founder
Bruce has a Master’s degree in Immunology and has more than 30 years experience in the development, manufacture and quality assurance and control of biological products including four years in the UK National Blood Transfusion Service and with the Nepalese Red Cross blood transfusion service. As Operations Site Manager at Intercell, he was responsible for all activities in their cGMP vaccine manufacturing plant. This included plant design, installation, commissioning and validation to obtain MHRA manufacturing licence and taking the lead product candidate from late stage development to successful licence submissions (BLA and MAA). Prior to this he was Director of Quality and Planning at Excell Biotech Ltd., a contract manufacturer of cGMP material for clinical trials, and QC Manager with Serologicals Ltd. an FDA licensed manufacturer of cGMP medical devices for diagnostic testing. Bruce is eligible to act as a Qualified Person under the permanent provisions of Directive 2001/82/EC and 2001/83/EC to act as QP for both licensed and investigational medicinal products. He is a Chartered Biologist and Member of the Institute of Biology (CBiol MIBiol). He is also Fellow of the Chartered Quality Institute (FCQI) and Fellow of the Institute of BioMedical Sciences (FIBMS). Bruce is currently consulting for a number of companies with products at various stages of development including some BioSimilar products.