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Analytical Development Principal Scientist, Microbiology & Viral Safety

Vertex Pharmaceuticals · Boston, MA

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CMCFull-time$141k–$211kCompany career page

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Role summary

Vertex Pharmaceuticals seeks a Principal Scientist to lead microbiology and viral safety testing strategies across development programs. The role requires deep expertise in microbiological and virological assays, supporting control strategy development, regulatory submissions, and commercial readiness for cell therapy, gene therapy, and biologics.

What they're looking for

  • Advanced degree in Microbiology, Virology, Biological Sciences, or related field; PhD preferred
  • PhD with 4+ years industry experience, or Master's with 7+ years, or Bachelor's with 10+ years
  • Demonstrated expertise in assay development, qualification, validation, transfer, and lifecycle management
  • Strong knowledge of regulatory expectations for microbiological and viral safety testing
  • Experience supporting regulatory submissions, inspections, and health authority interactions
  • Proficiency in cross-functional collaboration and scientific communication
  • Experience in cell and gene therapy, biologics, or advanced therapy medicinal products

What you'll be doing

  • Serve as subject matter expert for microbiology and viral safety assays across multiple development programs
  • Lead development, qualification, validation, and lifecycle management of microbiological and viral assays
  • Provide technical guidance on risk assessment, assay selection, and testing strategies to support product development
  • Author and review technical documentation, validation plans, and regulatory submissions
  • Drive innovation in rapid and alternative microbiological methods to improve testing efficiency and scalability

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