Senior Director, Companion Diagnostics

What this role involves

The Senior Director, Companion Diagnostics leads laboratory activities for teams focusing on commercial and developmental CDx programs. They oversee assay development and validation for cell therapy assays, ensuring regulatory compliance with FDA, ISO, CLIA, and CLSI standards. The role involves mentoring staff, managing client communications, and driving operational excellence.

Skills this posting asks for

• cell therapy assays
• fda regulations
• iso 13485
• iso 15189
• clia
• clsi
• gxp
• companion diagnostics
• large molecule bioanalysis
• assay development
• design control
• regulatory compliance
• protocol writing
• inventory management
• kpi monitoring
• sop development
• cell-based assays
• non-cell-based assays

Requirements

• Level: director
• Remote policy: onsite

From the employer’s posting

Position Summary: The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory activities for teams focused on supporting both commercially approved CDx sample analysis as well as CDx progr…