Scientist, QC Microbiology
Core
Subject matter expert in method transfer, validation, and routine microbiological testing for in-process, final product, and stability samples within a commercial cell therapy manufacturing facility.
Role type
Senior IC QC Microbiologist
Builds
Supports the validation and routine release of cell therapy products for patients with blood cancer.
Domain
Biopharmaceuticals / Cell Therapy / Microbiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiological testing techniques, GMP compliance, complex troubleshooting, technical writing, data verification, project management, CAPA handling, regulatory inspection support, mentoring
Preferred skills
Advanced degree in Science, LIMS/ELN proficiency, cross-functional collaboration
Technologies
LIMS, ELN
Responsibilities
Perform method transfer/verification/validation and routine testing of samples; Review testing data and GMP documentation; Execute complex troubleshooting and problem solving; Own project, CAPA, and deviation/investigation tasks; Author and review technical documents (SOPs, specifications); Train and mentor team members; Represent department in regulatory inspections
Seniority
Senior, hands-on IC
