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Brian

Biotech Manufacturing and CMC Specialist

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Summary

With over 20 years of experience in biotech manufacturing and development, Brian has excelled in technical and project management roles spanning mAbs, ADCs, cell and gene therapies, and other biologic modalities. He provides global clients with expert support across all CMC functional areas, from process development and cGMP manufacturing to regulatory affairs, guiding products from development through clinical stages.

Core Expertise

  • CMC Strategy and Execution 
  • Process Development and cGMP Manufacturing 
  • IND Module 3 Preparation and Regulatory Support 
  • CDMO Relationship and Supply Chain Management 
  • Project and Portfolio Management 

Career Highlights

  • Biotechnology Consultant: Advised multiple clients on supply chain risk mitigation during the pandemic and provided expert guidance on IND Module 3 submissions and responses at all clinical stages. 
  • Director of Project Management: Led cross-functional teams on CMC, pre-clinical, and clinical goals, driving cGMP manufacturing for novel vaccines and implementing company-wide CMC governance to enhance pipeline prioritization. 
  • Program Manager: Oversaw a $70MM portfolio of cGMP drug substance manufacturing programs, managing in/out-sourced operations, leading tech transfers, and achieving program objectives with CMOs. 

 

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