Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy
Core
Lead technical support, process validation, and technology transfer for clinical and commercial cell therapy manufacturing to ensure robust, compliant, and cost-effective production.
Role type
Principal Process Engineer (Cell Therapy Manufacturing)
Builds
Clinical and commercial cell therapy products
Domain
Biopharmaceuticals / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cell therapy unit operations, GMP compliance, deviation investigation, CAPA implementation, process validation, technology transfer, statistical analysis, technical writing, change control management, raw material qualification
Preferred skills
Late-stage clinical manufacturing support, commercial readiness experience
Technologies
Control charts, batch record systems, CMC regulatory frameworks
Responsibilities
Manage and mentor MS&T engineers; lead technical investigations for deviations and process excursions; conduct batch record reviews and data trending; author SOPs, batch records, and regulatory documents (Module 3); lead technology transfer activities and process validation (PPQ); provide on-floor technical support during critical campaigns and scale-out; drive continuous improvement through change controls.
Seniority
Principal, hands-on IC with team leadership