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Brian Mullan
About Brian Mullan
Head of Process and Analytical Development for Cell and Gene Therapies CDMO (pre-clinical to Phase III supply), focusing on AAV and Lentiviral vectors. Unit includes groups responsible for process development and validation, transfer to manufacturing, innovation, and analytical development. Member of company Executive Committee.
Previous experience as MS&T Head for commercial supply of biologics, and as Global CMC Lead for biologics programmes (pre-launch, commercial; drug substance and drug product). Solid experience in team leadership, GMP biologics manufacturing and process development, pharmaceutical programme management (including multiple process tech transfers), and Regulatory Affairs (CTD submissions [EU, USA, China, LatAm]), Pre-approval inspections, CMC strategies, Health Authority interactions). Track record of creating and maintaining relationships in challenging stakeholder environments.