Process Development Engineering Senior Scientist (MSAT), Cell and Gene Therapy Full-time

Manufacturing Science And Technology Leader

The successful candidate will be responsible for Manufacturing Science and Technology (MSAT) activities for cell therapy products in our Type 1 Diabetes (T1D) program as well as our gene therapy (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 cross-functional environment.

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 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
• Knowledge of cGXP theory and practices is 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.
• 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.