Director, Clinical Laboratory
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.
- 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.
- 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 firstname.lastname@example.org for a confidential discussion.
Job Reference: MSC-MDX-CLIA