Senior Process Engineer, Manufacturing, Science, and Technology (MSAT) Cell Therapy
Core
Ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products through hands-on technical support, process validation, and continuous improvement.
Role type
Senior hands-on IC process engineer (cell therapy manufacturing)
Builds
Clinical and commercial cell therapy products
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work
Required skills
Cell therapy unit operations, GMP batch record execution/review, deviation investigations, root cause analysis, CAPA implementation, statistical analysis (control charts, multi-variate), technical writing, change control management, technology transfer, process validation, comparability studies
Preferred skills
Late-stage clinical manufacturing support, commercial readiness, process validation expertise
Technologies
Electronic batch record systems, control charting tools, GMP documentation systems
Responsibilities
Provide on-the-floor technical support for critical manufacturing campaigns; lead deviation investigations and implement CAPAs; maintain manufacturing data tracking and perform trend analysis; author and revise batch records, SOPs, and technical reports; support technology transfers and process validation (PPQ); deliver operator training on critical process steps; collaborate with Quality, Supply Chain, and global functions on lifecycle management.
Seniority
Senior, hands-on IC