Senior Scientist, CGT Analytics & Method Validation

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Vertex Pharmaceuticals seeks a Senior Scientist in Analytical Sciences & Technology (AS&T) to lead commercial analytical activities for the CGT portfolio. You will provide SME support on assay development, validation, and method transfer, collaborating across Analytical Development, Process Development, Manufacturing, and Quality to ensure launch readiness and lifecycle management.

Role requires strong technical writing, regulatory knowledge, and experience with cGMP manufacturing of biologics.

Qualifications

• Proven track record in analytical method development and validation for biologics.
• Experience with CGT analytical testing and regulatory expectations (ICH/USP/EMA).
• Strong capability in technical writing and documentation.
• Ability to manage multiple projects and meet timelines with adaptability.

Responsibilities

• Accountable for the success of commercial analytical activities, prioritization, and execution to meet program commitments.
• SME for robustness of analytical methods and commercial testing requirements.
• Author and/or review technical documents, including method SOPs, study protocols and technical reports.
• Partner with internal and external functions for commercial analytical technology transfer.
• Lead analytical method validations, continuous improvement, and lifecycle management.
• Collaborate with cross-functional teams (Analytical Development, Process Development, Commercial Manufacturing, Supply Chain, Quality, and partners).
• Provide oversight for analytical testing and method performance at CDMOs and contract labs.

Skills

Analytical method development

CGT analytical testing

GMP knowledge

Technical writing

Project prioritization

Cross-functional collaboration

Education

Bachelor’s degree or above in Science or related discipline

6 years pharma/biopharma experience

Job description

Vertex Pharmaceuticals seeks a Senior Scientist in Analytical Sciences & Technology (AS&T) to lead commercial analytical activities for the CGT portfolio. You will provide SME support on assay development, validation, and method transfer, collaborating across Analytical Development, Process Development, Manufacturing, and Quality to ensure launch readiness and lifecycle management.

Role requires strong technical writing, regulatory knowledge, and experience with cGMP manufacturing of biologics.