Executive Director, MSAT – Type 1 Diabetes
Core
Strategic and hands-on leadership for Manufacturing Science & Technology (MSAT) across a global Type 1 Diabetes cell therapy manufacturing network, focusing on external partners (CMOs) to ensure processes are robust, scalable, and inspection-ready.
Role type
Executive Director, MSAT
Builds
GMP-compliant cell therapy manufacturing processes and supply chains for clinical and commercial launch
Domain
Biopharmaceuticals / Cell Therapy / Advanced Therapies
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP expectations for advanced therapies, control strategy development, process characterization, lifecycle management, deviation/investigation leadership, change control, comparability strategies, multi-site network management, CMO engagement, tech transfer leadership
Preferred skills
Cell therapy manufacturing experience, advanced biologics manufacturing, clinical and commercial program support, hybrid manufacturing models
Technologies
MES/eBR, historian integration, data pipelines, analytics
Responsibilities
Define and execute MSAT strategy for global external network; Establish governance models for CMO engagement; Lead process validation/PPQ strategies and continued verification; Drive integrated readiness plans for pivotal trials and commercial launch; Lead technical assessment and execution of change control across external sites; Build and mentor a high-impact MSAT organization
Seniority
Executive, strategic leadership & hands-on technical oversight