Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals (Boston)
Core
Providing scientific and technical expertise for late-stage and commercial separation methods, managing method lifecycle, validation, transfer, and troubleshooting for biologics programs.
Role type
Principal Scientist, Separation Methods Expert
Builds
Late-stage and commercial Biologics programs
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
analytical method development, validation, transfer, and lifecycle management for protein-based biologics; separation methods (chromatographic, electrophoretic); GMP, CLP, and regulatory guidance (ICH, USP/EP/JP); potency assays for registrational filings; statistical analysis tools (e.g., JMP)
Preferred skills
peptide mapping; mass spectrometry (MS)
Technologies
chromatographic separation modes; electrophoretic separation (CE, IEF); JMP
Responsibilities
Lead analytical method remediation, validation, and transfer for separation methods; Lead and support troubleshooting and investigations for in-process, release, and stability testing; Own Quality events and analytical related activities (Change Controls, Impact Assessments); Collaborate cross-functionally to support analytical readiness for worldwide commercialization; Support regulatory submissions and responses to inquiries from health agencies; Author technical documents (SOPs, validation/transfer protocols, risk assessments); Review method trending data and prepare APQRs
Seniority
Principal, hands-on IC
