Mark

Biopharmaceutical Development and Manufacturing Expert

Summary

Mark Rice brings over 20 years of experience in biopharmaceuticals, specializing in process development, GMP manufacturing, and project management. As a recognized subject matter expert in cell-line development, upstream process development, and biologics manufacturing, Mark has successfully guided clients in evaluating and managing CDMO partnerships. His leadership has driven improvements in facility design, quality systems, and biologics processing, ensuring seamless integration from development to production.

Core Expertise

  • Cell-Line Development and Upstream Process Development 
  • GMP Manufacturing for Biologics, Lentiviral Vectors, and Cell Therapies 
  • CDMO Evaluation, Selection, and Management 
  • IND Documentation (3.2.S and 3.2.A Sections) 
  • Facility Design and Process Optimization 

Career Highlights

  • Director: Served as an SME for cell-line development and upstream process development, overseeing CDMO selection and management for biologics and cell therapy programs.  
  • Director of Processing Facility: Managed the Biologics Processing Facility, producing GMP biologics, mammalian and microbial products, and lentiviral vectors.  
  • Director: Directed teams of over 20 scientists specializing in cell-line and upstream bioreactor processes. 

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