Process Development Engineering Principal Associate

General Summary: The Process Development Engineering Principal Associate 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 cross-functional environment.

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 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. Knowledge and Skills: 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. Experience with cell therapy products is preferred 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 Education and Experience: PhD in Life Sciences, chemical engineering, or related discipline or master’s degree with minimum 2+ years of industry experience or bachelor’s degree with 4+ years of relevant industry experience. Hands on experience with Manufacturing Science and Technology (MSAT) investigation and change management. Experience with cell-gene therapy is preferred. 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. Pay Range: $86,800 - $130,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive