Director, QC Microbiology, CTDO Quality Control

Role: Director of QC Microbiology at a CAR T facility, overseeing microbiology operations supporting stability, raw materials, in-process, and final product testing, environmental monitoring, and investigations. Responsibilities: manage all microbiology activities, including method validation, data analysis, and regulatory compliance; lead staff management, training, performance evaluations, and career development. Qualifications: Bachelor's in Chemistry, Microbiology, or related science; 10+ years of relevant experience; leadership experience with direct reports; deep knowledge of cGMP, ISO, FDA, and other regulations related to cell therapy manufacturing. High-Value: cell therapy (CAR T), microbiology, GMP environments, microbiological assays (endotoxin, mycoplasma, rapid sterility), regulatory inspections, and quality systems. Worksetup: office and laboratory in NJ, with on-call support; some travel expected.