MSAT Process Development Lead - Cell Therapy (On-Site)

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 87,000 - 130,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated is seeking a Process Development Engineering Principal Associate to lead MSAT activities for cell therapy products. The role includes transferring technology from Development to Clinical Manufacturing and PPQ, with cross-functional support and lifecycle improvements.

Responsibilities span triage, change control, and overseeing CDMOs, while driving continuous improvement, cost reductions, and commercial readiness.

Qualifications

• PhD in Life Sciences, chemical engineering, or related discipline; or master's with 2+ years of industry experience; or bachelor's with 4+ years of relevant industry experience.
• Hands-on experience with MSAT investigation and change management; experience with cell-gene therapy is preferred.
• Experience designing controls and risk management, including FMEA analyses.
• Direct industry experience with early and/or late-phase clinical/commercial cell or gene therapies.

Responsibilities

• Lead triage, investigation, and change control in MSAT and monitor manufacturing processes.
• Manage short- and long-term deliverables with defined milestones and timelines.
• Contribute to regulatory submissions (IND, IMPD) and author supporting documents.
• Coordinate cross-functional activities to align scope, schedule and budget.
• Drive continuous improvement, COGS reduction, and commercial readiness.
• Support pre-PPQ and PPQ activities.
• Establish robust process performance across clinical and commercial manufacturing lines.
• Oversee CDMOs and ensure performance, quality, and timely delivery.
• Collaborate within teams and contribute to issue resolution.

Skills

MSAT

Cell therapy

Cross-functional

FMEA

Regulatory knowledge

Process development

Education

PhD in Life Sciences

Chemical engineering

Bachelor's degree + experience

Job description

Vertex Pharmaceuticals Incorporated is seeking a Process Development Engineering Principal Associate to lead MSAT activities for cell therapy products. The role includes transferring technology from Development to Clinical Manufacturing and PPQ, with cross-functional support and lifecycle improvements.

Responsibilities span triage, change control, and overseeing CDMOs, while driving continuous improvement, cost reductions, and commercial readiness.