In collaboration with the clinical laboratory director, this position will play a critical function in multiple aspects of clinical molecular testing, including assay development, validation, test optimization, quality control, troubleshooting, and clinical case sign out.
Build Trust: Operate with transparency, no hidden agenda; place confidence in colleagues, give proper credit to others. Follow through on agreed upon actions. Treat sensitive or confidential information appropriately. Keep emotions under control. Exhibit ethical and moral behavior in everyday business conduct.
Foster Communication: Demonstrate ability to carefully listen to others at all levels of the organization. Seek and listen to feedback and be approachable. Express thoughts and ideas effectively. Display and promote cross cultural sensitivity.
Display Stewardship: Understand business implications of decisions. Conserve organization resources. Look for ways to improve and promote quality. Take personal responsibility. Use resources in an efficient and cost-effective manner.
- Interpret and report clinical molecular genetic test results for oncology and inherited diseases.
- Enhance laboratory procedures and systems to assure high quality, accurate clinical test results are produced by the laboratory at all times.
- Assist in trouble-shooting of technical laboratory procedures and provide technical support to laboratory staff; oversee the laboratory Quality Management plan and ensure laboratory maintains plan compliance.
- Consult with physicians, genetic counselors, and other clinical staff regarding technical specifications of tests. Answer questions and engage in discussions regarding the interpretation of patient results.
- Ensure continuous compliance with regulatory agencies (CAP, CLIA) and regulatory guidelines; assume a lead role during inspections (internal and external).
- Provide scientific and clinical assessment of emerging technologies and techniques through remaining current on scientific literature to improve current test methodologies and to develop new test offerings. Approve test method selection and validation plans.
- Ensure adherence to the proficiency testing program. Review and approve corrective action plans for any unsatisfactory proficiency testing results.
- Ensure appropriate SOPs are in place per regulatory requirements, perform annual review and approval of all laboratory SOPs.
- Assist the laboratory manager as needed in the training of laboratory technical staff; ensure staff receive appropriate level of training and are able to demonstrate technical performance of test procedures.
- Engage in scientific presentations at national meetings, contribute to peer-reviewed publications, and actively participate in professional organizations and societies.
Education: PhD or MD in Molecular Genetics, Pathology, or related discipline.
Experience: 3-5 years of experience in a CLIA/CAP clinical molecular genetics laboratory that performs next-generation sequencing for inherited diseases and oncology (to have included gene panel testing, whole genome and/or whole exome sequencing), reviewing and interpreting test data.
Certifications/Licenses: Board eligible or board certification in Clinical Molecular Genetics or Laboratory Genetics and Genomics by the American Board of Medical Genetics and Genomics or Molecular Genetic Pathology.
Knowledge, Skills and Abilities:
- Superior expertise and demonstrated proficiency in technical molecular genetics laboratory procedures
- Experience with interpretation and reporting of variants for inherited disorders
- Knowledge of high-throughput genotyping platforms and automated sequencing methods
- Excellent interpersonal, organizational, and analytical skills; Demonstrated written and verbal communication skills
- Thorough understanding of regulatory requirements as they relate to clinical laboratory (CLIA/CAP) operations
- Team player, comfortable interacting with all levels of management; able to champion an opinion or push back when necessary
- Candidate must work well with other industry thought-leaders, scientists, strategic partners, the broader scientific / medical community