QC Principal Scientist - Microbiology (Cell Therapy)
Core
Strategic oversight of microbial control activities, method transfers, validation projects, and complex trend analysis for Cell Therapy operations.
Role type
Principal Scientist (Microbiology, Cell Therapy)
Builds
Personalized cell therapies meeting global regulatory standards
Domain
Biopharmaceuticals / Cell Therapy / Microbiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Sterility Testing, Endotoxin analysis, Microbial ID/Genomics, cGMP principles, global pharmacopeia (USP, EP, JP), Quality Systems (TrackWise, LIMS), root cause analysis (RCA), CAPA implementation, SOP/protocol authoring, data mining and trend analysis
Preferred skills
Advanced Graduate Degree (Master's or PhD), experience managing complex QC projects, mentoring junior staff
Technologies
TrackWise, LIMS
Responsibilities
Lead authoring and execution of protocols for method transfers, qualifications, and validations; Provide expert guidance to internal operations and contracted suppliers; Act as primary technical witness and SME in regulatory inspections (FDA, EMA); Perform and lead high-complexity deviation and investigation activities; Review laboratory records and approve QC SOPs, protocols, and specifications; Troubleshoot assay and instrumentation issues through advanced data mining and trend analysis
Seniority
Principal, strategic oversight and mentorship
