Senior Manager, QC Analytical-1
Core
Lead and oversee QC Analytical lab operations for clinical and commercial cell therapy drug product testing (in-process, release, stability) ensuring cGMP compliance and data integrity.
Role type
Senior Manager, QC Analytical (Cell Therapy)
Builds
QC programs and functional areas for cell therapy drug products
Domain
Biopharmaceuticals / Cell Therapy / Quality Control
Required skills
Leadership and team management, Bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry), cGMP and data integrity compliance, Root cause analysis and CAPA, Operational excellence (Lean, Six Sigma), Regulatory inspection representation, KPI development and reporting
Preferred skills
Laboratory LIMS/ELN/ERP systems (DeltaV, SAP), Advanced degree in science
Technologies
LIMS, ELN, DeltaV, SAP, Excel, Visio, PowerPoint
Responsibilities
Lead QC Analytical lab ensuring effective testing and data review; Develop, track, and report KPIs for performance; Own and maintain QC programs; Hire, mentor, and develop team members; Approve test methods, procedures, and documents; Approve change controls, investigations, deviations, and CAPAs; Serve as escalation point for cross-functional partners; Represent department in regulatory inspections and audits; Provide on-call and shift coverage support.
Seniority
Senior Manager, people leader