MSAT Process Development Engineering Scientist (Contract)

Vertex Pharmaceuticals; Boston (MA); On-site; USD 82,656 - 92,299; Part time

Job summary

Vertex Pharmaceuticals in Boston, MA seeks a Process Development Engineering Scientist to lead MSAT activities for cell therapy programs. This onsite, 6‑month contract role focuses on technology development, transfer from Development to Clinical Manufacturing, and PPQ support.

The candidate will drive continuous improvement, lifecycle management, and cross-functional collaboration, including CDMO oversight and risk-based approaches. A PhD or Master’s with experience is required.

Qualifications

• PhD in Life Sciences, chemical engineering, or related discipline or Master’s degree with minimum 3+ years of industry experience or Bachelor’s degree with 6+ years of relevant industry experience.

Responsibilities

• Lead triage, investigation, and change control as an MSAT assessor; identify improvements and monitor manufacturing processes.
• Manage delivery of short- and long-term milestones; identify program risks and communicate strategies.
• Review and contribute to regulatory submissions (IND, IMPD); author supporting documents and reports.
• Coordinate cross-functional activities to align scope, schedule and budget.
• Drive continuous improvement and lifecycle management; reduce COGS and enable commercial readiness.
• Champion pre-PPQ and PPQ activities.
• Establish robust process performance across clinical and commercial manufacturing lines; lead process monitoring and lifecycle initiatives.
• Oversee CDMOs by providing guidance and ensuring performance and delivery.

Skills

MSAT experience

Change management

Regulatory filings

Cell processing

Cross-functional leadership

Process transfer

Lifecycle management

Team training

Education

PhD in Life Sciences or chemical engineering

Master’s degree with 3+ years industry

Bachelor’s degree with 6+ years industry

Job description

Job Description

Process Development Engineering Scientist

Vertex, a biopharmaceutical company focused on developinga celland gene-based therapies for multiple indications, is seeking a Process Development Engineering Scientist to join our Process Development - Technical Sciences group in Boston, MA.

The successful candidate will be responsible for Manufacturing Science and Technology (MSAT) activities for cell therapy products in our Type 1 Diabetes (T1D) program andCasgevyprogram. The candidate will provide cross-functional leadership in technology development and transfer from Development to Clinical Manufacturing and Process Performance Qualification including internal operations and potentially various CDMOs. The candidate will also plan and implement continuous improvement initiatives for life-cycle management working in cross-functional environment.

This role is onsite.

6 month contract with chance to extend.

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

• Review and 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.

• Champion 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.

Preferred qualifications:

• PhD in Life Sciences, chemical engineering, or related discipline orMaster’sdegree with minimum 3+ years of industry experience orBachelor'sdegree with 6+ years of relevant industry experience.

• Hands onexperience with Manufacturing Science and Technology (MSAT) investigation and change management. Experience with cell-gene therapy is preferred.

• Hands onexperience with regulatory filings is preferred.

• Experience working with cell processing, specifically with primary cells. Experience with cell therapy products is preferred

• Knowledge ofcGXPtheory andpracticesis required.

• Ability to communicate effectively with a diverse range of scientists, engineers, regulatory specialists, and business professionals

• Proven experience with MSAT, Process Technology Transfer, Technical Operations, and Lifecycle Management.

• Knowledge of Design Control and Risk Management, including experience using FMEA analyses.

• Must be able to work independently with adequate supervision and support in parallel a few projects.

• Must demonstrate strong interpersonal and teamwork skills, with experience managing and training team.

Pay Range

$60-$67/HR

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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