Manager, QC Microbiology, Cell Therapy
Core
Manage the QC Microbiology Laboratory supporting CAR T manufacturing, ensuring microbiological testing of in-process samples, final products, utilities, and components meets regulatory standards.
Role type
Manager, QC Microbiology (Cell Therapy)
Builds
Supports final product testing and release, incoming component release, and critical utilities monitoring for cell therapy manufacturing.
Domain
Biopharmaceuticals / Cell Therapy / Microbiology
Required skills
Microbiology (isolation, identification, enumeration), cGMPs, Regulatory compliance (FDA, MHRA, PMDA), Quality Systems (SOPs, Deviations, CAPAs), Leadership, Data integrity, Statistics, Validation principles, Safety regulations
Preferred skills
Cell therapy product experience, Sterile compounding/filling operations, Regulatory audits, Advanced degree, 2+ years leadership
Technologies
eQMS, Microsoft Office Suite (Word, Excel, PowerPoint)
Responsibilities
Manage QC Microbiology department and personnel; Coordinate testing program scheduling; Develop and manage SOPs; Ensure compliance investigations and CAPAs; Act as SME during regulatory inspections; Train and develop direct reports.
Seniority
Manager, hands-on leadership