Nathalie

Biopharma Technical Specialist

Summary

Natalie Thompson is a seasoned biopharma technical consultant with over 10 years of experience spanning peptides to cell therapy. She excels in assay development, validation, and regulatory support, offering meticulous project management and fostering transparent collaboration across cross-functional teams. With deep expertise in analytical methods and Module 3 regulatory documentation, Natalie ensures quality and compliance throughout the product lifecycle.

Core Expertise

  • Assay Development, Validation, and Transfer 
  • Analytical Project Management and Regulatory Documentation (eCTD Module 3) 
  • Product Characterization and Process Control Strategies 
  • CDMO/CRO Selection and Collaboration 
  • Quality Attribute Identification and Phase-Appropriate Testing 

Career Highlights

  • Technical Consultant: Managed Phase 3 analytical method validation, including assay performance reviews, regulatory document drafting, and equipment recommendations for recombinant proteins and cell and gene therapy products. 
  • Senior Scientist: Led analytical teams for recombinant vaccine process characterization, managing inter-departmental deliverables and coordinating method qualification and tech transfers with Quality Control. 
  • Analytical and Quality Expert: Supported assay development and technology transfer activities, identified critical quality attributes, and collaborated with CRO/CDMOs to maintain productive partnerships for biopharma projects. 

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