Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals (Boston)
Vertex Pharmaceuticals
July 01, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
The Analytical Science and Technology (AS&T) Principal Scientist, Separation Method Expert, provides scientific and technical expertise for late-stage and commercial methods and vendor management. Manages the method life cycle (remediation, validation, transfer, troubleshooting, investigations for OOT/OOS) and data trending analysis. Partners with stakeholders and contract testing sites to ensure cGMP and Quality Management compliance.
Key Duties And Responsibilities:
- Lead analytical method remediation, validation, and transfer for separation methods for late-stage and commercial biologics.
- Lead and support troubleshooting and investigations for in-process, release, and stability testing.
- Own quality events and analytical activities (Change Controls, Impact Assessments, Change Actions) related to analytical methods.
- Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for commercialization and product lifecycle.
- Ensure on-time deliverables and accountability for project success.
- Support IND/BLA regulatory submissions and inquiries as analytical method SME.
- Author technical documents (method SOPs, validation/transfer protocols and reports, bridging, risk assessments).
- Work with CMO/CTO/external partners on work requests, product characterization, and technology transfers.
- Review method trending data and prepare APQRs.
Knowledge And Skills:
- Expertise in analytical method development/validation/transfer/lifecycle management for protein-based biologics.
- Hands-on separation methods: chromatography (various modes), electrophoretic (CE, IEF), and/or impurity methods (biologics).
- Familiar with GMP, CLP, ICH, USP/EP/JP as applicable; proficiency with potency assay regulatory requirements for filings.
- Statistical tools knowledge (e.g., JMP) desired.
- Excellent technical communication and writing; ability to manage multiple priorities and timelines.
Education And Experience:
- PhD/Master’s/Bachelor’s in biochemistry, chemical engineering, or related field.
- Typically: PhD + 5+ years; Master’s + 8+ years; Bachelor’s + 10+ years relevant experience.
Pay Range:
- $138,400 - $207,600
The Analytical Science and Technology (AS&T) Principal Scientist, Separation Method Expert, provides scientific and technical expertise for late-stage and commercial methods and vendor management. Manages the method life cycle (remediation, validation, transfer, troubleshooting, investigations for OOT/OOS) and data trending analysis. Partners with stakeholders and contract testing sites to ensure cGMP and Quality Management compliance.
Key Duties And Responsibilities:
- Lead analytical method remediation, validation, and transfer for separation methods for late-stage and commercial biologics.
- Lead and support troubleshooting and investigations for in-process, release, and stability testing.
- Own quality events and analytical activities (Change Controls, Impact Assessments, Change Actions) related to analytical methods.
- Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for commercialization and product lifecycle.
- Ensure on-time deliverables and accountability for project success.
- Support IND/BLA regulatory submissions and inquiries as analytical method SME.
- Author technical documents (method SOPs, validation/transfer protocols and reports, bridging, risk assessments).
- Work with CMO/CTO/external partners on work requests, product characterization, and technology transfers.
- Review method trending data and prepare APQRs.
Knowledge And Skills:
- Expertise in analytical method development/validation/transfer/lifecycle management for protein-based biologics.
- Hands-on separation methods: chromatography (various modes), electrophoretic (CE, IEF), and/or impurity methods (biologics).
- Familiar with GMP, CLP, ICH, USP/EP/JP as applicable; proficiency with potency assay regulatory requirements for filings.
- Statistical tools knowledge (e.g., JMP) desired.
- Excellent technical communication and writing; ability to manage multiple priorities and timelines.
Education And Experience:
- PhD/Master’s/Bachelor’s in biochemistry, chemical engineering, or related field.
- Typically: PhD + 5+ years; Master’s + 8+ years; Bachelor’s + 10+ years relevant experience.
Pay Range:
- $138,400 - $207,600