Senior Process Engineer, Manufacturing Sciences & Technology, Cell Therapy
Core
Senior Process Engineer ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products.
Role type
Senior hands-on IC process engineer (cell therapy)
Builds
Cell therapy manufacturing campaigns, validated processes, and commercial-ready products
Domain
Biopharmaceuticals / Cell Therapy
Required skills
Cell therapy unit operations, GMP batch execution, deviation investigation, CAPA implementation, process validation, technology transfer, statistical analysis, technical writing, data trending, change control management
Preferred skills
Late-stage clinical manufacturing support, commercial readiness, process characterization
Technologies
Electronic batch records, control charts, risk assessment tools
Responsibilities
Provide on-the-floor technical support for critical manufacturing campaigns; Lead deviation investigations and implement CAPAs; Execute technology transfers and process validations; Author SOPs, batch records, and regulatory documents (Module 3); Conduct data trending and process performance monitoring; Support raw material qualification and automation initiatives.
Seniority
Senior, hands-on IC