Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals (Boston)
Core
Lead analytical method remediation, validation, transfer, and troubleshooting for separation methods used in late-stage and commercial Biologics programs.
Role type
Principal Scientist, Separation Methods Expert
Builds
Analytical methods and data for Biologics product lifecycle and commercialization
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Separation methods (chromatography, electrophoresis), Method validation & transfer, cGMP compliance, Regulatory submissions (IND/BLA), Technical writing, Data trending analysis
Preferred skills
Peptide mapping, Mass Spectrometry (MS), Statistical analysis tools (JMP)
Responsibilities
Lead method remediation, validation, and transfer; Support troubleshooting for in-process, release, and stability testing; Author technical documents (SOPs, protocols, reports); Collaborate with stakeholders on analytical readiness; Review method trending data and prepare APQRs
Seniority
Principal, hands-on IC
