Principal Scientist, Separation Methods Expert, Analytical Science and Technology (AS&T), Vertex Pharmaceuticals (Boston)
Vertex Pharmaceuticals
September 03, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
The AS&T Principal Scientist, Separation Method Expert provides scientific/technical expertise for late-stage & commercial separation methods and vendor management. Manages method life cycle (remediation, validation, transfer, troubleshooting, OOT/OOS investigations) and data trending. Partners with stakeholders and contract testing sites to ensure compliance with cGMP and Quality Management systems.
Key Duties and Responsibilities:
- Lead analytical method remediation, validation, and transfer for separation methods (late-stage and commercial biologics).
- Lead/support troubleshooting and investigations for in-process, release, and stability testing.
- Own analytical-related Quality events (Change Controls, Impact Assessments, Change Actions).
- Collaborate cross-functionally and with external partners for global commercialization and product lifecycle activities.
- Ensure on-time deliverables and project/activity success.
- Serve as analytical method SME for regulatory submissions (IND/ BLA) and health agency inquiries.
- Author technical documents (method SOPs, validation/transfer protocols/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.
Qualifications/Skills:
- Expertise in analytical method development/validation/transfer and lifecycle management for protein-based biologics.
- Hands-on separation methods: chromatography, electrophoretic (CE/IEF), and/or impurity methods (required).
- GMP/CLP and regulatory guidance familiarity (ICH, USP/EP/JP).
- Potency assay regulatory proficiency (required); peptide mapping/MS is a plus.
- Statistical tools knowledge (e.g., JMP) desired; strong technical writing and communication.
- Prioritization and timeline management across multiple projects.
Education/Experience:
- PhD, Master’s, or Bachelor’s in Biochemistry, Chemical Engineering, or related field.
- Typically: PhD (5+ yrs), Master’s (8+ yrs), or Bachelor’s (10+ yrs).
Pay Range:
- $138,400 - $207,600.
Flex Designation:
- Hybrid: remote up to two days/week or On-Site: five days/week with ad hoc flexibility.
The AS&T Principal Scientist, Separation Method Expert provides scientific/technical expertise for late-stage & commercial separation methods and vendor management. Manages method life cycle (remediation, validation, transfer, troubleshooting, OOT/OOS investigations) and data trending. Partners with stakeholders and contract testing sites to ensure compliance with cGMP and Quality Management systems.
Key Duties and Responsibilities:
- Lead analytical method remediation, validation, and transfer for separation methods (late-stage and commercial biologics).
- Lead/support troubleshooting and investigations for in-process, release, and stability testing.
- Own analytical-related Quality events (Change Controls, Impact Assessments, Change Actions).
- Collaborate cross-functionally and with external partners for global commercialization and product lifecycle activities.
- Ensure on-time deliverables and project/activity success.
- Serve as analytical method SME for regulatory submissions (IND/ BLA) and health agency inquiries.
- Author technical documents (method SOPs, validation/transfer protocols/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.
Qualifications/Skills:
- Expertise in analytical method development/validation/transfer and lifecycle management for protein-based biologics.
- Hands-on separation methods: chromatography, electrophoretic (CE/IEF), and/or impurity methods (required).
- GMP/CLP and regulatory guidance familiarity (ICH, USP/EP/JP).
- Potency assay regulatory proficiency (required); peptide mapping/MS is a plus.
- Statistical tools knowledge (e.g., JMP) desired; strong technical writing and communication.
- Prioritization and timeline management across multiple projects.
Education/Experience:
- PhD, Master’s, or Bachelor’s in Biochemistry, Chemical Engineering, or related field.
- Typically: PhD (5+ yrs), Master’s (8+ yrs), or Bachelor’s (10+ yrs).
Pay Range:
- $138,400 - $207,600.
Flex Designation:
- Hybrid: remote up to two days/week or On-Site: five days/week with ad hoc flexibility.