Principal Scientist (PD/MSAT)
Core
Lead process development and analytical method development for fully-automated cell therapy manufacturing at a CDMO site, scaling regenerative medicines for patients.
Role type
Principal Scientist (Process Development / Manufacturing Science and Analytical Technology)
Builds
Automated cell manufacturing sites and scalable cell therapy products
Domain
Regenerative medicine, cell therapy, biomanufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cell therapy development and manufacture (PD to MSAT to cGMP), Human stem cell culture optimization (ESC/iPSC), Regulatory compliance (MHRA/EMA/FDA), Quality documentation for cGMP, Project leadership with multiple dependencies, Experimental design and analytical skills, Line management
Preferred skills
Phase I clinical trial experience, CDMO operations experience
Technologies
Custom robotics, automated cell manufacturing systems
Responsibilities
Provide technical leadership for CDMO site setup and operation, Lead process and analytical method development, Plan and execute technology transfer activities, Drive continuous process improvement, Support resource planning and timeline development, Mentor colleagues and support hiring, Engage in business development and sales proposal drafting
Seniority
Principal, hands-on IC with leadership responsibilities
