Process Development Engineering Principal Associate

Vertex Pharmaceuticals · Boston, MA

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CMCFull-time$87k–$130kCompany career page

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Role summary

Vertex Pharmaceuticals seeks a Process Development Engineering Principal Associate to lead manufacturing science and technology activities for cell therapy products. The role involves process development, regulatory support, and continuous improvement across clinical and commercial manufacturing operations, including coordination with external contract manufacturers.

What they're looking for

PhD in Life Sciences or chemical engineering, or Master's degree with 2+ years industry experience, or Bachelor's degree with 4+ years relevant experience
Hands-on experience with Manufacturing Science and Technology investigation and change management
Experience with cell processing, particularly primary cells and cell therapy products
Knowledge of Design Control, Risk Management, and FMEA analyses
Direct industry experience developing early or late-phase clinical/commercial cell or gene therapies
Excellent communication and organizational skills with strong attention to detail
Ability to build collaborative relationships and work effectively in multidisciplinary teams

What you'll be doing

Lead triage, investigation, and change control implementation for manufacturing processes as MSAT functional assessor
Manage execution of short and long-term deliverables with defined milestones and timely risk communication
Contribute to regulatory submissions including IND and IMPD, authoring supporting documents and reports
Coordinate cross-functional activities and drive continuous improvement initiatives for COGS reduction and commercial readiness
Oversee CDMO activities, ensuring performance, quality, and delivery standards are met

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