Senior Specialist II, Quality Control Validation
Core
Overseeing method validation and validation readiness for cell and gene therapy programs transitioning from early clinical phase to commercial manufacturing.
Role type
Senior Specialist II, Quality Control Validation
Builds
Validated test methods, protocols, and documentation for commercial manufacturing
Domain
Biotechnology / Cell and Gene Therapy / Quality Control
Required skills
GMP compliance, method validation planning, data analysis, regulatory standards knowledge, SOP management, change control oversight, team mentorship
Preferred skills
Cell and gene therapy manufacturing experience, LIMS/CMMS/QMS/ERP systems proficiency
Technologies
qPCR, ddPCR, Flow Cytometry, ELISA, cell-based assays
Responsibilities
Define validation strategy, plan, and protocol; collaborate with Analytical Development and QC testing functions; analyze data and report results; ensure equipment/software/SOPs are appropriate for validation; support inspections and audits; hire, train, and mentor staff
Seniority
Senior, hands-on IC