Senior Specialist, Manufacturing NPI & Clinical Readiness
Core
Enabling clinical and commercial manufacturing readiness for cell therapy products through ownership of manufacturing documentation, MES recipe readiness, automation, change control impact assessment, clinical run coordination, and operator training.
Role type
Senior individual contributor manufacturing specialist (cell therapy/biologics)
Builds
Manufacturing batch records, SOPs, MES recipes, and operational readiness for clinical and commercial cell therapy campaigns
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Required skills
GMP documentation authorship, MES/electronic batch record system experience, aseptic/sterile manufacturing principles, manufacturing risk assessment (FMEA), change control impact assessment, cross-functional team coordination, technical writing, operator training
Preferred skills
Cell therapy or biologics manufacturing experience, experience with technical transfer and validation runs, ability to mentor junior specialists
Technologies
MES systems, electronic batch records (EBR), FMEA tools
Responsibilities
Author and manage lifecycle of manufacturing batch records, SOPs, and O&M procedures; Collaborate with IT/MES teams to design, test, and deploy electronic batch records and recipes; Lead manufacturing risk assessments and define mitigation strategies; Coordinate clinical run readiness huddles and support engineering/validation runs; Develop and deliver operator training on new processes and systems; Perform change control impact assessments and execute resulting actions
Seniority
Senior, hands-on IC