Gloria Lefkowitz Email Address

GenMark provides multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care.

Experienced assay development scientist. A reliable problem solver with a proven record of successfully launched products that contribute to improved patient diagnosis. Contributed to entire lifecycle of product development for LDTs (feasibility, development, verification, validation, launch, and post-launch). Renovated single-plex assay to multiplex platform, saving time and money and reducing repeat rates by end user. Provided support post-launch to ensure successful transition to new assay. Areas of Expertise: Cell biology, molecular biology, biochemistry CRISPR-Cas, genomics, early and late stage IVD development, multiplex PCR, rt PCR, qPCR, luminex SNP genotyping, Western blot, ELISA immunoassays, clincial validation, design control Interested in: Project Management, Lean Six Sigma, DOE, Design Control, IVD, 510K, GMP, strategic planning