MSAT Process Development Engineering Scientist

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 communicating strategies.
• Review and contribute to regulatory submissions (IND, IMPD). Author supporting documents and reports.
• Cook up 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 discussions on issue resolution.

Requirements

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