This commercial Clinical Diagnostics company is developing and performing new assays to guide treatment of chronic kidney disease (CKD) and inform medical decision making in kidney transplant. Chronic kidney disease afflicts roughly 30 million American adults with over 90% of individuals who have CKD unaware that they have it. There are currently few treatments beyond alleviating symptoms. The company and therefore the laboratory operations will rapidly expand in scope and scale in 2020 and will continue its mission of developing novel assays and tools to advance patient care and outcomes. The company pairs laboratory science with artificial intelligence to create innovative solutions.
We are looking for a Clinical Laboratory Technical Supervisor with at least five years of experience in a NYSDOH/CLIA/CAP/FDA regulated environment and a passion for developing new diagnostics. Our novel tests include measurement of circulating protein biomarkers in blood by immunoassay and a range of sequencing-based tests in both blood and tissue. The ideal candidate will have experience in developing immunoassay and molecular diagnostic test methods and have prior experience in execution and reporting of clinical diagnostic testing. We are seeking a candidate with the drive and ambition for career growth as part of a dynamic organization.
Team: Report to the Head of Clinical Laboratory Operations. Supervise the daily activity of medical laboratory and development scientists. Engage with core functions within the company including Medical Director, Product Development, Administrative and Quality Assurance on delivery of shared objectives.
Duties and Responsibilities:
- Responsible for the technical oversight of the laboratory
- Must be accessible to the laboratory staff to provide on-site, telephone, or electronic consultation
- Performs diagnostic immunology and/or molecular laboratory assays in all three phases: pre-analytic, analytic and post-analytic to maintain proficiency at laboratory bench skills
- Verification of the test procedures performed and establishment of the laboratory’s test performance characteristics, including the precision and accuracy of each test and test system
- Recognizes unusual patient results and identifies problems in analytical procedures or systems; responds with appropriate investigation and corrective / preventive actions as needed. Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications
- Organizes and improves laboratory work-flows and processes to maximize efficiency
- Establishes a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results
- Maintains and reviews quality control records, monitoring quality control measures and identifying opportunities for quality improvement
- Recognizes and promptly reports any quality control issues to Laboratory Management or Medical Director
- Schedules participation in approved proficiency programs, assigns proficiency testing activities, and reports results in a timely manner
- Performs activities for inspection-readiness for NYSDOH/CLIA/CAP/FDA
- Ensures compliance with safety programs and procedures including blood borne pathogens, hazardous chemical waste disposal, and environmental services
- Participates in continuing education activities and maintains records to continue active ASCP accreditation
- Identifies team training needs and assures that each individual performing testing receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed
Requirements and Education:
Bachelor’s degree in Clinical Laboratory Science or equivalent and minimum of five-seven years of experience, with a minimum of 2 years in a supervisory role.
ASCP certification in Clinical Laboratory Science.
Must hold a current or be immediately eligible for a New York State Clinical Laboratory license.
Experience working in a regulated environment. Experience in assay performance and analytical analyses and trouble-shooting is highly desired. Experience in a broad range of instrumentation use including immunoassay and molecular diagnostic platforms. Experience in use of Laboratory Information Systems (LIMS).
- Success in leading, training and developing Clinical Laboratory Scientists
- Familiarity with multiplex immunoassay platforms is highly preferred
- Experience performing molecular assays is highly preferred
- Demonstrated competency in planning, execution and reporting of assay validations
- Competitive salary and full benefits package
- Opportunity to develop, validate and perform diagnostics that are cutting-edge
- Chance to develop novel tools and tests that impact millions
- Opportunity to grow with a high-growth potential organization
|Job Category||Clinical Laboratory|