Process Development Engineering Senior Scientist - MSAT (Contract)

Atrium Works • Boston, MA

19h • Onsite

About The Position

Vertex, a biopharmaceutical company focused on developing cell and gene-based therapies for multiple indications, is seeking a Process Development Engineering Senior 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 and Casgevy program. 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 a cross-functional environment. This role is one site. 12-month contract with a chance and likelihood to extend.

Requirements

• Knowledge of cGXP theory and practices is required.
• A strong understanding of statistical analyses is required, as are strong technical writing and presentation skills.
• 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.

Nice To Haves

• PhD in Life Sciences, chemical engineering, or related discipline with minimum 2+ years of relevant industrial work experience or Master’s degree with minimum 5+ years of industry experience or Bachelor's degree with 8+ 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.
• Hands on experience with regulatory filings is preferred.
• Experience working with cell processing, specifically with primary cells.
• Experience with cell therapy products is preferred.
• Proven experience with MSAT, Process Technology Transfer, Technical Operations, and Lifecycle Management.
• Knowledge of Design Control and Risk Management, including experience using FMEA analyses.

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 a 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.

Benefits

• compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
• eligible for overtime pay, in accordance with federal and state requirements

What This Job Offers

• Job Type: Full-time
• Career Level: Senior