Executive Director/Site Head

Position Summary:

The Executive Director / Site Head of Precision for Medicine (located onsite in Frederick, MD) will be responsible to oversee the laboratory operations across 3 different functional groups in Frederick, Maryland. This role is responsible for ensuring that lab environments, processes, and systems are optimized to enable scientific and operational excellence while maintain regulatory compliance. A critical requirement is deep current knowledge of FDA guidance documents and requirements, along with the ability to put these requirements into practice developing robust assays that easily pass FDA scrutiny. Experience with developing and managing programs following FDA/IVDR,. ISO 13485 and 15189 principles of design control, understanding of both CLIA and CLSI validation requirements, and assay execution of both cell-based and non-cell-based assays is required.  

Essential functions of the job include but are not limited to:

• Full responsibility of operational aspects for all laboratories in Frederick MD; including Bioanalysis, Flow Cytometry and Companion Diagnostic.
• Support, hire, coach and mentor laboratory lab heads in Bioanalytical, Flow and CDx
• Collaborate with site supporting departments: Facilities, Biorepository, Quality Assurance, Finance, as