Senior Analytical Scientist, CGT Launch (Hybrid)

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

Job summary

Vertex Pharmaceuticals LLC is seeking a Senior Scientist in Analytical Sciences & Technology (AS&T) to support launch readiness and lifecycle management for the commercial CGT portfolio. You will lead analytical method development, validation, and technology transfer, collaborating across Analytical Development, Process Development, Commercial Manufacturing, and Quality teams.

With a strong GMP background and experience in biologics, you will ensure testing readiness for CDMOs and external labs,

Qualifications

• Demonstrated expertise in analytical method development, characterization, and qualification/validation for biologics.
• Knowledgeable in ICH/USP/EMA guidelines with a strong GMP background.
• Experience managing contract (CTO/CDMO) analytical testing, highly desirable.
• Experience with technical support of commercial biological products and cGMP manufacturing.

Responsibilities

• Accountable for the success of commercial analytical activities, prioritization, and execution to meet program commitments.
• Subject Matter Expert for ensuring the robustness of analytical methods and commercial testing requirements.
• Author and/or review technical documents, including method SOP, study protocol and technical report.
• Partners effectively with internal and external functions for commercial analytical technology transfer.
• Oversight for analytical testing and method performance executed at CDMOs and contract testing labs.

Skills

Analytical method development

Biologics knowledge

GMP background

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree or higher in Science or related discipline

Job description

Vertex Pharmaceuticals LLC is seeking a Senior Scientist in Analytical Sciences & Technology (AS&T) to support launch readiness and lifecycle management for the commercial CGT portfolio. You will lead analytical method development, validation, and technology transfer, collaborating across Analytical Development, Process Development, Commercial Manufacturing, and Quality teams.

With a strong GMP background and experience in biologics, you will ensure testing readiness for CDMOs and external labs,