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Responsible for the transition of technology from development to production environments, ensuring seamless scaling and adaptation to GMP production for viral vectors. Duties include documentation, data analysis, collaboration with cross-functional teams, and maintaining compliance with regulatory standards.

The Process Engineer is responsible for supporting engineering and technical disciplines related to gene therapy processes. Key responsibilities include project management, compliance monitoring, quality control, and implementing safety management systems. This role emphasizes workflow optimization and the enhancement of facilities, ensuring adherence to FDA standards while driving continuous improvement initiatives.

The individual will establish processes in Downstream Process Development, ensuring scalable platform production of viral vectors. Responsibilities include process optimization, monitoring performance, maintaining compliance with regulations, and collaborating with stakeholders. The role requires leading design for single-use systems and serving as a subject matter expert for audits.