Senior Specialist, Manufacturing NPI & Clinical Readiness
Core
Senior specialist enabling clinical and commercial manufacturing readiness for cell therapy products through documentation, MES recipe management, risk assessments, and operator training.
Role type
Senior individual contributor manufacturing NPI specialist
Builds
Manufacturing batch records, SOPs, MES recipes, and risk mitigation strategies for cell therapy
Domain
Biopharmaceuticals / Cell therapy manufacturing
Required skills
GMP documentation, MES/electronic batch record systems, aseptic/sterile manufacturing, risk assessment (FMEA), change control impact assessment, UAT for automated recipes, cross-functional coordination
Preferred skills
Cell therapy or biologics experience, operator training expertise, technical transfer support
Technologies
MES systems, electronic batch records, FMEA tools
Responsibilities
Author and manage manufacturing batch records, SOPs, and O&M procedures; Lead risk assessments and define mitigation strategies; Coordinate clinical run readiness huddles and execution; Develop and deliver operator training; Support MES recipe design, testing, and deployment; Mentor junior specialists
Seniority
Senior, hands-on IC
