Days - Full-Time
Hospital Main Campus, KS
Position Summary/Career Interest
This person will be working for the Division of Genomic Diagnostics in a CAP accredited molecular laboratory. The Senior Scientist will be responsible for a wide variety of molecular diagnostics and quality assurance duties to ensure regulatory compliance. The role is responsible for development of new assays & instruments and provides technical oversite of the clinical operation in collaboration with the laboratory Director and the Assistant Director.
Key skills are the ability to communicate effectively both orally and in writing; strong organizational and interpersonal skills; ability to prioritize work, meet deadlines and be meticulous; ability to work both independently and collaboratively in a dynamic setting; and proficiency in computing and internet skills, including the use of in-house and online databases and browsers
- Must be able to perform the professional, clinical and or technical competencies of the assigned unit or department.
- Perform new test development and clinical validation under the direction of the assistant director;
- Validate/verify analytical performance; install, maintain and calibrate instrumentation; implement appropriate quality control activities;
- Perform high complexity molecular laboratory tests including nucleic acid extractions, analytical testing performance, data analysis, and reporting, as required, to meet CMOL testing service needs;
- Recognize problems and initiate troubleshooting steps to evaluate testing failures and other problems;
- Write standard operating procedures (SOPs) for new tests and help update existing protocols as needed;
- Conduct quality control and quality assurance of test systems, reagents and instrumentation, as appropriate, including assisting the development of quality standards for new tests and procedures and participating in proficiency testing;
- Train technical staff regarding new assays and evaluate the competency of testing personnel;
- Assist the assistant director to resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
- Perform PCR- and NGS-based molecular oncology testing in accordance with standard operating procedures for the diagnosis and treatment of various types of cancer;
- Assists with NGS data analysis and variant assessment review using validated workflows;
- Prepare, test and evaluate new reagents or controls;
- Utilize a wide array of instrumentation, including MiSeq, NextSeq, ABI 3500 xL and ABI 7500 Fast Dx instruments, performing routine maintenance, quality control and calibrations, as required.
- Accurately enter results of testing and review reports to ensure accurate test result reporting in preparation for review by a Director;
- Review, interpret, and report patient results reliably, accurately, and with integrity;
- Interact collaboratively with other laboratory directors, laboratory staff, genetic counselors, and teams across the University of Kansas Health System;
- Comply with applicable federal, state, and local regulations and maintain familiarity with company SOPs and practices and applicable professional guidelines;
- Help write and refine report text;
- Help evaluate and refine NGS gene panels offered by the laboratory as needed;
- Analyze data for presentation or publication as needed;
- Review scientific literature, attend scientific meetings, and lead the bi-monthly molecular tumor board;
- Compile information and coordinate resources for billing compliance, laboratory information systems, and other hospital departments, as needed.
- Additional duties as assigned.
Experience with next-generation sequencing (NGS) technologies.
2 years of prior experience in a clinical laboratory environment.
Medical Laboratory Scientist, MLS(ASCP)CM or Technologist in Molecular Biology, MB(ASCP)CM
Familiar with NGS variant analysis and interpretation (oncology).