Sr Director, Process Development
Core
Lead the Manufacturing Science & Technology (MSAT) organization for a commercial cell therapy facility, ensuring robust, compliant, and reliable operations for personalized CAR T-cell therapies.
Role type
Senior Director, Manufacturing Science & Technology (MSAT)
Builds
Commercial cell therapy manufacturing operations, validated processes, and scalable supply chains for cancer immunotherapies.
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cell therapy manufacturing expertise, Biologics process development, Global GMP compliance, Technology transfer leadership, Process validation, Lifecycle management, Operational automation strategy, Root-cause analysis, Regulatory submission support, Cross-functional stakeholder influence
Preferred skills
Commercial cell therapy experience, Aseptic processing knowledge, Single-use systems expertise, Quality by Design (QbD), Six Sigma, Executive-level communication
Technologies
Single-use systems, Automation systems, Data science tools for manufacturing
Responsibilities
Define and execute site MSAT strategy, operating plan, and budget; Build and develop high-performing teams of managers and technical leaders; Lead technical governance and risk-based decision-making for manufacturing; Oversee shop-floor support, investigations, and process improvements; Lead technology transfer and lifecycle management; Govern the validation lifecycle using data science; Set direction for MSAT laboratories and automation; Lead technical content for regulatory submissions; Represent site priorities in global forums; Sponsor cross-site initiatives for operational excellence.
