Process Engineer

About Genetix Biotherapeutics

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Role Summary:
As a Process Engineer II in the Manufacturing Sciences and Technology (MSAT) team at Genetix, you will play a pivotal role in ensuring the seamless technology transfer and technical support of our platform in cGMP manufacturing. This position focuses on supporting ongoing commercial production, execution of projects within the CMC lifecycle and tech transfer. You will collaborate closely with Technical Development, Quality, and our CDMO (Contract Development and Manufacturing Organization) partners to guarantee that all aspects of technology transfer and technical support are executed effectively.

Key Responsibilities:

• Act as the primary technical expert for supporting the GMP production of autologous cell therapies at our CDMO partners.
• Conduct complex manufacturing investigations using root cause analysis tools to determine underlying causes and develop corrective and preventive actions to prevent recurrence.
• Develop and maintain process trending and continued process verification programs to ensure processes remain in a controlled state.
• Drive a culture of continuous improvement and operational excellence through the identification and execution of key projects that enhance process performance.
• Serve as a core team leader for cross-functional tech transfer teams, coordinating and tracking program progress within various workstreams.
• Prepare and review technical documentation including process descriptions, sampling plans, process training materials, risk assessments, study protocols, and technical reports.
• Utilize scientifically sound reasoning and statistical tools for data analysis, contributing to a deeper understanding of processes, identifying sources of variability, and resolving product and process failures.
• Provide hands-on support for tech transfer and GMP runs, serving as the lead Person in Plant (PiP).