Senior Manager, QC Analytical-1
Core
Lead 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 Operations
Builds
Cell therapy drug product testing programs and quality assurance workflows
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 readiness
Preferred skills
Laboratory LIMS/ELN/ERP systems experience, Advanced degree in science
Technologies
LIMS, ELN, DeltaV, SAP, Excel, Visio, PowerPoint
Responsibilities
Oversee QC Analytical lab for timely and efficient testing; Develop and report KPIs for performance; Lead continuous improvement initiatives; Hire, mentor, and develop team members; Approve test methods, procedures, and documents; Manage change controls, investigations, and deviations; Represent department in regulatory inspections and audits
Seniority
Senior, hands-on IC with management responsibilities