Process Development Engineering Principal Associate

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 87,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Annual equity awards

On-site role

Job summary

Vertex Pharmaceuticals LLC in Boston, MA seeks a Process Development Engineering Principal Associate to lead MSAT activities for cell therapy products. You will support development-to-manufacturing transfers and lifecycle improvements, including change control, risk management, and collaboration with CDMOs.

The role emphasizes cross-functional leadership, regulatory contribution, and a focus on continuous improvement and commercial readiness, with on-site work five days a week and a strong Total

Qualifications

• 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.

Responsibilities

• Lead MSAT triage, investigation, and change control as a functional area assessor.
• Manage timely deliverables with milestones, identify program risks and communication strategies.
• Contribute to regulatory submissions (IND, IMPD) and author supporting documents.
• Coordinate cross-functional activities to align scope, schedule and budget.
• Drive continuous improvement and lifecycle management for both clinical and commercial manufacturing.

Skills

Excellent communication

Collaborative relationships

Cell processing experience

Design Control and Risk Management

FMEA experience

MSAT/Cell/gene therapy experience

Organizational skills

Education

PhD in Life Sciences

Chemical engineering

Master's degree + 2+ years

Bachelor's degree + 4+ years

Job description

## Process Development Engineering Principal AssociateApply: Boston, MA: Full time: Posted Today: REQ-30175**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:**$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 market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**On-Site Designated**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.