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 release, incoming component testing, and critical utilities monitoring for cell therapy manufacturing.
Domain
Biopharmaceuticals / Cell Therapy / Microbiology
Required skills
cGMPs, FDA/USP/MHRA/PMDA regulations, Microbiology techniques, Validation principles, Data integrity, Statistics, Leadership, Deviations/CAPAs management
Preferred skills
Cell therapy product experience, Sterile compounding/filling operations, Regulatory audits experience, Advanced degree
Technologies
eQMS, Microsoft Office Suite, Biosafety Level 2 equipment
Responsibilities
Manage QC Microbiology department and personnel scheduling; Develop and manage SOPs and testing methods; Ensure compliance with regulatory guidelines; Investigate deviations and implement CAPAs; Act as SME during regulatory inspections; Train and evaluate direct reports.
Seniority
Manager, hands-on leadership