CASY-MSCCN Jobs

Req #: 232507

Department: LABORATORY MEDICINE AND PATHOLOGY

Posting Date: 03/22/2024

Closing Info: Open Until Filled

Salary: $8,681 - $10,834 per month

Shift: First Shift

Notes: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701_a11y.pdf )

As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills and dedication to build stronger minds and a healthier world.

UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty.

The Senior Scientist of Clinical and Regulatory Development (Research Scientist/Engineer-Senior (E S 10)) will supervise technical development of clinical assays and optimization of high-complexity molecular and cytogenomic assays and process improvement that will be used for the Genetics division, including liaising with the Molecular Hematopathology laboratory. This will include coordinating staff efforts in research and clinical development efforts across division laboratories

DUTIES AND RESPONSIBILITIES Clinical Development Responsibilities This individual will oversee and coordinate the research and clinical development and validation of new genomic based diagnostics testing in the Genetics Division.

• Responsible for the development of research and clinical projects and experiments in Genetics, to support research in optimizing high-complexity clinical molecular and cytogenomic assays, and process improvements that will be used for the Genetics Division, including liaising with the Molecular Hematopathology laboratory. This will include coordinating research and clinical development efforts across laboratories in the division.

• Lead harmonization efforts across the Genetics research and clinical laboratories, including the use of automated platforms such as liquid handlers.

• Develop process improvements in workflow of advanced technologies used in division laboratories, including next-generation sequencing based tests.

• Develop and implement clinical research validation to be used for genetic and genomic test services based on next-generation sequencing and other advanced technologies.

• Facilitate and lead the research process of streamlining and harmonization of wet bench procedures for next-generation sequencing workflows across Genetics Division laboratories.

• Plans, develops, and coordinates research and development of technical workflows and facilities of Genetics Division laboratories.

• Oversee the creation of technical clinical development documentation (validation document, procedures) for new and updated Genetics Division tests from research to specification required by regulatory agencies, including CAP, CLIA, FDA, Study Sponsors, and PIs.

• Participate in the strategic planning to develop and review current Genetic Division technical development plans and assist in planning for annual division research and clinical development technical goals and objectives.

• With oversight from the division head, interact with laboratory clients (physician and other medical providers) related to aspects of technical clinical development and regulatory questions or concerns.

• Assist in test interpretation and test reporting from research and clinically validated tests.

• Participate in the development and review of high-complexity quality control data for Genetics Division laboratories.

• Participate, as needed, in teaching of undergraduates, graduate students, residents, and fellows.

• Participate in research and scholarship related to the Genetics Division leadership.

• Other duties as assigned.Regulatory Responsibilities

• With Division Head oversight, works with clinical laboratory, research scientists, and faculty to design a comprehensive quality assurance and quality control (QA/QC) program to ensure division laboratories maintain highest quality data standards.

• Work with clinical teams to develop and maintain division wide regulatory and compliance programs, including service directors, clinical genomics analysis team, clinical laboratories, preanalytical team, and NGS Analytics team.

• Review validation reports for new clinical assays, changes in testing methodology, and subsequent impacts on bioinformatics pipelines for reporting.

• Overall oversight of the Technical Assessment and Z-code program, including scheduling, assigning, performing, and reviewing technical work required for technical assessment and Z-code submission.IT responsibilities

• Partner with the NGS Analytics, UW and Department IT, and Program Operations Team to implement changes and improvements, including building and implementing metric and quality assurance dashboards.Supervisory Responsibilities

• Supervise Quality Assurance Specialist and Clinical Development staff.

• Interview, hire, orient, and training new employees to maintain qualified technical staff and competency quality assurance staff; maintain documentation of training and required competencies.

• Delegate responsibilities, duties, and tasks to optimize the use of staff time, skill, and expertise without compromising quality.

• Assess and adjust staff, considering workload, turnover, and budget; plan staff schedules and rotations; assign staff to projects; act upon vacation and leave requests.

• Review and evaluate employee performance; provide fair and immediate feedback on job performance for staff; counsel staff to improve performance as required; recommend disciplinary or remedial action as needed.

• Mentor staff to be highly competent on clinical and research regulatory requirements.

• Coordinate continuing education and in-service education for staff. MINIMUM REQUIREMENTS

• PhD in Genetics, Molecular Cell Biology, Biochemistry or Life Sciences with at least 6 years of applicable experience.

• OR Masters degree in Genetics, Molecular Cell Biology, Biochemistry or Life Sciences with at least 8 years of applicable experience.

• OR Master’s degree with exceptional qualification may substitute for minimum requirements; OR equivalent experience may substitute for degree requirement.

• Professional Certification of ASCP (American Society of Clinical Pathologist) and at least four years of clinical technologist experience.

• Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. ADDITIONAL REQUIREMENTS

• Experience in molecular biology methods and data analysis.

• Experience with instrumentation associated with next-generation sequencing (NGS) including Illumina sequencing instruments and automated liquid handling instruments used in NGS.

• Strong teamwork and interpersonal skills. Strong organizational and documentation skills suitable to a clinical laboratory environment.

• Experience in regulatory affairs in clinical diagnostics.

• To include at least 3 years of leadership experience. DESIRED QUALIFICATIONS

• Ph.D. in Genetics, Molecular Cell Biology, Biochemistry, or other Life Sciences,

• Project Management experience.

• Experience with next-generation sequencing and/or cytogenomic laboratory methods.

• Understanding of the principles of cancer genetics and clinical molecular diagnostics.

• Familiarity with standard bioinformatics tools and databases. Application Process: The application process may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are access ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.

University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.