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Analytical Development Principal Scientist

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 analytical control strategy development for small molecule drug substances across clinical and commercial phases. The role involves designing process development activities, setting specifications, and serving as a subject matter expert for contract manufacturing partners.

What they're looking for

  • Ph.D. with 4+ years analytical development experience for novel small molecules
  • Working knowledge of control strategy development, spike/purge studies, and QbD principles
  • Strong understanding of cGMP, ICH, FDA, and USP guidelines including impurity controls
  • Skilled in modern chromatographic and analytical methods for small molecule pharmaceuticals
  • Background in synthetic organic chemistry and drug substance development processes
  • Excellent verbal and written communication skills
  • Ability to work independently and in matrix team environments

What you'll be doing

  • Design and oversee drug substance analytical activities across development phases using QbD principles
  • Set and justify specifications for drug substances, intermediates, and starting materials
  • Identify critical in-process control issues and develop appropriate IPC methods
  • Serve as subject matter expert liaison with contract manufacturing and testing laboratories
  • Develop analytical methods suitable for progressive stages of pharmaceutical development

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