Process Development Engineering Scientist (Contract)

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 83,000 - 92,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA is seeking a Process Development Engineering Scientist to lead MSAT activities for cell therapy programs and drive cross-functional technology development and transfer from Development to Clinical Manufacturing and PPQ. The role focuses on lifecycle management, continuous improvement, and collaboration with CDMOs, with strong emphasis on regulatory readiness.

The 12-month contract role is onsite, with responsibilities spanning process development, process

Qualifications

• PhD in Life Sciences, chemical engineering, or related discipline or Master’s degree with 3+ years of industry experience or Bachelor’s degree with 6+ years of relevant industry experience.
• Hands-on MSAT investigation and change management experience; cell-gene therapy experience is preferred.
• Experience with regulatory filings is preferred; cell processing experience is a plus.
• Strong communication with scientists, engineers, regulatory specialists, and business professionals.
• Knowledge of Design Control and Risk Management, including FMEA analyses.

Responsibilities

• Lead triage, investigation, and change control as a Manufacturing Science and Technology assessor.
• Coordinate cross-functional activities to align scope, schedule and budget.
• Review regulatory submissions (IND, IMPD) and author supporting documents.
• Drive continuous improvement, cost of goods reduction, and commercial readiness.
• Oversee CDMO activities and ensure performance, quality and delivery.

Skills

MSAT

Process development

Tech transfer

PPQ processes

Lifecycle management

CQA/CGXP knowledge

Regulatory submissions

Cross-functional leadership

CDMOs collaboration

Risk assessment

Education

PhD in Life Sciences or chemical engineering

Master’s degree + 3+ years experience

Bachelor’s degree + 6+ years experience

Tools

IND/ IMPD familiarity

cGXP theory and practice

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.

12 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

No C2C or Third-Party Vendors