MSAT Process Development Lead, Cell Therapy

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

Benefits offered by this job

Annual bonus

Equity awards

Paid time off

Commuting subsidy

401(k)

Job summary

Vertex Inc. seeks a Process Development Engineering Principal Associate to lead MSAT activities for cell therapy products, supporting development to clinical manufacturing and PPQ.

You will coordinate cross-functional teams, drive continuous improvement, and oversee external collaborators to ensure process performance and readiness for commercial manufacturing. The role emphasizes implementation of lifecycle management, risk-based improvements, and regulatory support, with on-site

Qualifications

• PhD in Life Sciences, chemical engineering, or related field; or master's with 2+ years of industry experience; or bachelor's with 4+ years.
• Hands on MSAT investigation and change management; cell-gene therapy preferred.

Responsibilities

• Lead triage, investigation, and change control in MSAT; identify improvements.
• Manage execution of deliverables with milestones and timelines.
• Contribute to regulatory submissions (IND, IMPD).
• Coordinate cross-functional activities to align scope, schedule and budget.
• Drive continuous improvement and lifecycle management.
• Oversee CDMOs and ensure performance and delivery.
• Collaborate within teams and resolve issues.

Skills

Communication skills

Collaboration

Cell processing

Cell therapy experience

Design Control & Risk Mgmt

FMEA

MSAT investigations

Organizational skills

Education

PhD in Life Sciences or related

Master's degree with 2+ years industry

Bachelor's degree with 4+ years industry

Job description

Vertex Inc. seeks a Process Development Engineering Principal Associate to lead MSAT activities for cell therapy products, supporting development to clinical manufacturing and PPQ.

You will coordinate cross-functional teams, drive continuous improvement, and oversee external collaborators to ensure process performance and readiness for commercial manufacturing. The role emphasizes implementation of lifecycle management, risk-based improvements, and regulatory support, with on-site