Senior MSAT Process Development Lead — Cell Therapy

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

Benefits offered by this job

Healthcare benefits

Paid time off

Equity awards

Annual bonus

Job summary

Vertex Pharmaceuticals seeks a Process Development Engineering Principal Associate to lead MSAT for cell therapy manufacturing. The role spans development transfer, PPQ readiness, and lifecycle improvements, with cross‑functional coordination across internal ops and CDMOs to ensure quality and scalability.

You will drive continuous improvement, support regulatory filings (IND/IMPD), monitor process performance, and guide external partners to deliver on milestones in a fast-paced, onsite

Qualifications

• PhD in Life Sciences, chemical engineering, or related field (or equivalent).
• 2+ years industry experience if Master's; 4+ years if Bachelors.
• Hands-on MSAT investigation and change management experience.

Responsibilities

• Lead triage, investigations, and change control in MSAT for cell therapy processes.
• Manage delivery milestones, risks, and communication across programs.
• Contribute to regulatory submissions (IND, IMPD) and supporting documents.
• Coordinate cross-functional activities to align scope, schedule, and budget.
• Drive continuous improvement and lifecycle management with risk mitigation.
• Oversee CDMOs and ensure performance, quality, and delivery.
• Collaborate with teams to resolve issues and share findings.

Skills

Communication

Collaboration

Cell processing

Design Control

Risk Management

Clinical/cell therapy development

Education

PhD in Life Sciences or chemical engineering

Master's with 2+ years industry

Bachelor's with 4+ years industry

Tools

FMEA

Job description

Vertex Pharmaceuticals seeks a Process Development Engineering Principal Associate to lead MSAT for cell therapy manufacturing. The role spans development transfer, PPQ readiness, and lifecycle improvements, with cross‑functional coordination across internal ops and CDMOs to ensure quality and scalability.

You will drive continuous improvement, support regulatory filings (IND/IMPD), monitor process performance, and guide external partners to deliver on milestones in a fast-paced, onsite