Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals (Boston) Job at Vertex Pharmaceuticals, Boston, MA

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  • Vertex Pharmaceuticals
  • Boston, MA

Job Description

Principal Scientist position leading analytical separation methods expertise for late-stage and commercial biologic programs at a pharmaceutical company. Responsibilities include method remediation, validation, transfer, and lifecycle management, with cross-functional collaboration across internal and external partners.

Responsibilities

  • Lead method remediation, validation, and transfer for separation methods in late-stage and commercial biologic programs
  • Conduct troubleshooting and investigations for in-process, release, and stability testing
  • Own quality events and analytical activities including change controls, impact assessments, and analytical method-related actions
  • Author technical documents including SOPs, validation protocols, reports, and regulatory submissions for biologics programs
  • Collaborate with CMOs, CTOs, and external partners on method transfer, product characterization, and regulatory submissions

Requirements

  • PhD in Biochemistry, Chemical Engineering, or related field; or Master's with 8+ years relevant experience; or Bachelor's with 10+ years
  • Demonstrated expertise in analytical method development, validation, transfer, and lifecycle management for protein-based biologics
  • Hands-on experience with chromatographic and electrophoretic separation methods, and impurity characterization for biologics
  • Proficiency with GMP, regulatory guidance (ICH, USP/EP/JP), and potency assay requirements for registrational filings
  • Strong technical writing skills and ability to collaborate with internal and external stakeholders
  • Experience with statistical analysis tools and data trending for analytical methods

Compensation: $138,400 - $207,600 base

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