JOB DETAILS

Director, Clinical Laboratory

Scientific

Cartwright James are exclusively partnered with a molecular diagnostics company with a focus on the early detection of cancer.

I am looking to connect with experienced Clinical Laboratory leaders with a proven track record in the MDx space.

Responsibilities:

• Provide technical and product support leadership in Operations working cross-functionally with the Production, QC, Supply Chain, R&D and Quality teams.
• Lead and support troubleshooting of Out of Specifications (OOS), non-conformances (NCMRs), customer complaints and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis and reporting.
• Provide support to Operations teams for qualifying and validating new raw materials and alternative supply channels for products.
• Analyze, track, and trend historical Production and Quality Control data.
• Lead and support design of CAPA plans working closely with Quality Teams.

Requirements:

• Bachelor’s degree in Life Sciences, or related field.
• 7+ years of experience with medical device products in a development or product support role.
• 3+ years of hands on experience in molecular biology and biochemical techniques.
• Knowledge of statistical and mathematical methods in biology/genetics, including experience JMP software.
• Knowledge and experience working within FDA regulated 21 CFR 820 environment, ISO 13485 and/or cGMP structured environment.
• Understanding of IVD product manufacturing processes, biochemical, molecular & real-time-PCR Assays.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Please reach out to poppy.moore@cartwrightjames.com for a confidential discussion.

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