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Senior Director, Companion Diagnostics: Regulatory Lead

Precision Medicine Group, LLC. · Hood College, Frederick County

$149,760 per year · Full-Time · Posted 10 hours ago

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About the job

Precision Medicine Group, LLC. is seeking a Senior Director, Companion Diagnostics to oversee lab activities in Frederick, MD. The role focuses on cell therapy assay design, development and validation to support both commercial CDx and developmental programs, with strong emphasis on FDA guidance, ISO 13485, and CLSI/CAP/CLIA compliance. The ideal candidate will mentor staff, manage cross-functional projects, and collaborate with QA/Regulatory to ensure delivery and client satisfaction. J-18808-…

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