Director, QC Microbiology, CTDO Quality Control
Core
Director of Quality Control Microbiology managing stability testing, raw material/in-process/final product testing, environmental monitoring, method validations, investigations, and data analysis for cell therapy products.
Role type
Senior IC Director (Quality Control Microbiology)
Builds
Cell therapy products (CAR T)
Domain
Biopharmaceuticals / Cell Therapy
Required skills
cGMP/ISO/FDA/MHRA/PMDA/USP/PDA/JP/EP regulations, Microbiology (endotoxin, mycoplasma, sterility, EM), Quality Systems (SOPs, CAPAs, Risk Assessments), Data Integrity, Budget Management, Team Leadership, Strategic Planning, Laboratory Design, Troubleshooting, Regulatory Inspection Representation
Preferred skills
Advanced degree in Chemistry/Microbiology, Lean Lab initiatives
Technologies
MS Office, Automated EM plate readers
Responsibilities
Manage QC Microbiology department activities (stability, testing, EM, validations, investigations), Manage and develop direct reports (scheduling, training, performance), Design microbiology lab space and drive lean initiatives, Represent department in regulatory inspections
Seniority
Director, strategic leadership with hands-on oversight