Senior Specialist, CAR-T Lifecycle Management
Core
Support the production of personalized cell therapy products for global clinical trials and commercial supply, managing multidisciplinary projects and process automation inputs.
Role type
Senior Specialist, Process Engineering & Lifecycle Management
Builds
Personalized CAR-T cell therapy products for clinical and commercial use
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing support)
Required skills
cGMP compliance, process engineering, project management, change management, root cause analysis, technical documentation, risk mitigation, data organization, industry standards knowledge (PDA, ISPE), single-use technologies, closed systems, cold chain/cryogenic technologies
Preferred skills
CAR-T manufacturing experience, biopharmaceutical manufacturing, Quality Control, ERP/MES relationship knowledge
Technologies
Electronic batch record systems, process automation technologies, MES, ERP
Responsibilities
Provide on-floor process support for manufacturing activities, develop inputs for process automation, participate in project teams for scheduling and execution, support change and process improvement initiatives, interface with operations as a process SME, monitor and optimize end-to-end processes, execute test plans and risk mitigation exercises, maintain experimental data, revise technical documentation, interact with cross-functional teams (Validation, Development, Operations, QA, Regulatory), participate in plant operating meetings, support health authority inspections, train and mentor junior associates
Seniority
Senior, hands-on IC with project management and mentorship duties
