Senior Process Engineer, Manufacturing Sciences & Technology, 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 Process Engineer (Cell Therapy Manufacturing)
Builds
Cell therapy products for clinical and commercial use
Domain
Biotechnology / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cell therapy unit operations expertise, GMP environment experience, statistical analysis, technical writing, problem-solving, data trending, deviation investigation, CAPA implementation, change control management, raw material qualification, automation partnership, regulatory documentation (CMC Module 3), operator training
Preferred skills
Late-stage clinical manufacturing support, process validation and commercial readiness experience
Technologies
Electronic batch record systems, control charts, statistical analysis tools
Responsibilities
Provide on-the-floor technical support for critical manufacturing campaigns; lead deviation investigations and implement CAPAs; perform data trending and analysis to ensure process robustness; support technology transfers and process validation (PPQ); author SOPs, batch records, and regulatory reports; deliver operator training and knowledge transfer; collaborate cross-functionally on lifecycle management and continuous improvement.
Seniority
Senior, hands-on IC