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

Job description

Job Description General Summary: 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. Coordin...