Process Development Engineering Principal Associate

Job Description

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.

Key Duties and 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 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:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.  

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]