Manager, QC Microbiology, Cell Therapy
Core
Manage the QC Microbiology Laboratory supporting CAR T manufacturing, including in-process and final product testing, utilities monitoring, and regulatory compliance.
Role type
Manager, QC Microbiology (Cell Therapy)
Builds
Supports final product testing and release, incoming component testing, and critical utilities monitoring for cell therapy manufacturing.
Domain
Biopharmaceuticals / Cell Therapy / Microbiology
Required skills
cGMPs, FDA/USP/MHRA regulations, Microbiology techniques, Data integrity, Statistics, Leadership, Deviations/CAPAs management, SOP development, Regulatory audit support, Safety compliance (BSL-2, OSHA)
Preferred skills
Advanced degree in Microbiology, Cell therapy product experience, Sterile compounding/filling operations experience, Regulatory audit participation (FDA/MHRA/PMDA/TGA), Quality Systems experience
Technologies
eQMS, Microsoft Office Suite (Word, Excel, PowerPoint), Biosafety cabinets, Incubators, Cryogenic equipment
Responsibilities
Manage QC Microbiology department and personnel scheduling; Develop and manage SOPs and testing methods; Ensure compliance with FDA/MHRA/PMDA regulations; Investigate deviations and implement CAPAs; Act as SME during regulatory inspections; Support validation and requalification activities.
Seniority
Manager, hands-on leadership