MSAT Process Development Scientist - Cell Therapy

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 83,000 - 92,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA is seeking a Process Development Engineering Scientist to lead MSAT activities for cell therapy programs and drive cross-functional technology development and transfer from Development to Clinical Manufacturing and PPQ. The role focuses on lifecycle management, continuous improvement, and collaboration with CDMOs, with strong emphasis on regulatory readiness.

The 12-month contract role is onsite, with responsibilities spanning process development, process

Qualifications

• PhD in Life Sciences, chemical engineering, or related discipline or Master’s degree with 3+ years of industry experience or Bachelor’s degree with 6+ years of relevant industry experience.
• Hands-on MSAT investigation and change management experience; cell-gene therapy experience is preferred.
• Experience with regulatory filings is preferred; cell processing experience is a plus.
• Strong communication with scientists, engineers, regulatory specialists, and business professionals.
• Knowledge of Design Control and Risk Management, including FMEA analyses.

Responsibilities

• Lead triage, investigation, and change control as a Manufacturing Science and Technology assessor.
• Coordinate cross-functional activities to align scope, schedule and budget.
• Review regulatory submissions (IND, IMPD) and author supporting documents.
• Drive continuous improvement, cost of goods reduction, and commercial readiness.
• Oversee CDMO activities and ensure performance, quality and delivery.

Skills

MSAT

Process development

Tech transfer

PPQ processes

Lifecycle management

CQA/CGXP knowledge

Regulatory submissions

Cross-functional leadership

CDMOs collaboration

Risk assessment

Education

PhD in Life Sciences or chemical engineering

Master’s degree + 3+ years experience

Bachelor’s degree + 6+ years experience

Tools

IND/ IMPD familiarity

cGXP theory and practice

Job description

Vertex Pharmaceuticals LLC in Boston, MA is seeking a Process Development Engineering Scientist to lead MSAT activities for cell therapy programs and drive cross-functional technology development and transfer from Development to Clinical Manufacturing and PPQ. The role focuses on lifecycle management, continuous improvement, and collaboration with CDMOs, with strong emphasis on regulatory readiness.

The 12-month contract role is onsite, with responsibilities spanning process development, process