Process Development Engineering Principal Associate

Vertex Inc.•Boston, MA

2d•$86,800 - $130,200•Onsite

About The Position

The Process Development Engineering Principal Associate is responsible for Manufacturing Science and Technology (MSAT) activities for cell therapy products. The candidate will provide cross-functional support in technology development and transfer from Development to Clinical Manufacturing and Process Performance Qualification, including internal operations and potentially various CDMOs. They are also responsible for planning and implementing continuous improvement initiatives for life-cycle management, working in a cross-functional environment. At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Requirements

Excellent communication skills to exchange technical/scientific information to a wide variety of audiences.
Ability to build collaborative relationships and work effectively as a member of a multidisciplinary team.
Experience working with cell processing, specifically with primary cells.
Knowledge of Design Control and Risk Management, including experience using FMEA analyses.
Direct industry experience developing early and/or late phase clinical/commercial cell or gene therapies.
Excellent organizational skills and high attention to detail.
Hands on experience with Manufacturing Science and Technology (MSAT) investigation and change management.

Nice To Haves

Experience with cell therapy products is preferred.
Experience with cell-gene therapy is preferred.

Responsibilities

Lead triage, investigation, and change control implementation as a Manufacturing Science and Technology functional area assessor and identify improvements, implement changes, and monitor clinical and commercial manufacturing processes.
Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and timelines. Minimize timeline deviations by clearly identifying program risks and communication of strategies.
Contribute to regulatory submissions (IND, IMPD). Author supporting documents and reports.
Coordinate and integrate cross-functional activities to ensure alignment in scope, schedule and budget.
Drive continuous improvement activities and operational excellence, including COGS reduction and commercial readiness.
Support pre-PPQ and PPQ activities.
Establish robust process performance across all clinical and commercial manufacturing lines, including process development, process improvement, and maintenance of process excellence. Lead process monitoring, continuous improvement, and lifecycle management initiatives guided by risk assessment and mitigation strategies.
Oversee CDMOs activities by providing guidance and support in a collaborative manner. Be responsible for the performance, quality and delivery of external collaborators.
Collaborate within departmental teams, actively contribute to deliverables and engage in team discussion on issue resolution.