St. Jude Children’s Research Hopsital is seeking a Technical Director for Molecular Diagnostics who will be responsible for overseeing the technical, scientific and regulatory aspects of the Molecular Pathology Laboratory. The Technical Director will work with the Molecular Laboratory Medical Director, attending pathologists, and laboratory staff to implement new tests and to improve existing assays in accordance with regulatory guidelines (CAP, CLIA, ISO 15189). Additional responsibilities include planning, organization, and oversight of all technical and administrative aspects of the Molecular Pathology Laboratory. The technical director is expected to interface with clinical and laboratory staff.
Preferred skills and experiences:
- Knowledge of CLIA, CAP, regulations, required; knowledge of ISO 15189 regulations.
- Ability to write laboratory procedures and policies.
- Ability to work independently and in a multidisciplinary team-based environment.
- Experience with complex molecular genetic methodologies, including next generation sequencing, methylation array, RT-PCR, and other molecular assays.
- Demonstrated ability to supervise, teach, train personnel.
- Excellent oral and written communication skills.
- Demonstrated good decision-making, critical thinking and organizational skills.
- Fiscal management experience including budget preparations, reporting, and financial analysis.
- A high degree of computer literacy, including knowledge and ability to use laboratory/hospitals information systems.
- EPIC experience.
- As directed by and in collaboration with the Medical Director, the Technical Director:
- Plans and oversees new assay design, feasibility studies, clinical validations, and transference of tests to production.
- Evaluates, recommends and implements new technologies, procedures, reagents, and workflows as needed.
- In conjunction with the laboratory manager and supervisor, the Technical Director coordinates, prioritizes, and directs resource allocation for test development and implementation.
- Reviews assay validations prior to implementation in the clinical laboratory and ensures comprehensive, accurate, and organized record keeping of experimental procedures and validation data/results according to regulatory guidelines.
- Oversees the day-to-day operations of the Molecular Pathology Clinical Laboratory with assistance from the laboratory manager and laboratory supervisor.
- Defines operational and scientific goals and infrastructure to align with defined leadership strategy.
- Assesses, recommends and implements improvements to standard operating procedures (SOPs), reports, workflows, processes, interfaces, infrastructure, test systems, scope of the laboratory, etc. In conjunction with the laboratory manager, ensures that the laboratory test menus, SOPs and policies are consistently updated.
- Assists in developing, coordinating and supporting the laboratory’s plans and programs for the standardization and automation of testing and processes.
- Effectively communicates ideas, progress and data to laboratory staff and leadership.
- Understands, interprets, and maintains compliance in laboratory section with all regulations of accrediting/licensing agencies. Ensures maintenance of required laboratory records for all required inspections. Assists with and oversees the preparation of the laboratory for regulatory inspections
- Ensures that all clinical testing data meets required quality metrics prior to reporting and is actively involved in the troubleshooting of quality issues as needed.
- Ensures timely resolution of technical and operational issues.
- Ensures that all necessary actions are taken and appropriately documented whenever significant deviations from the laboratories’ established performance specifications are identified.
- Develops and implements policies, procedures and quality assurance measures; ensures compliance.
- Follows and upholds appropriate safety regulations.
- Assists with staff hiring and orientation.
- In conjunction with laboratory manager identifies training needs and ensures that each lab staff receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. Ensures initial training and competency and maintenance of competency for all laboratory testing personnel. Ensures that all section employees are knowledgeable in current section technologies and skills.
- Assumes responsibilities for continuing educational for self and laboratory staff.
- Counsels and disciplines employees with the advice/consent of Laboratory Administration and Human Resources as needed.
- Assists laboratory manager with cost analyses and annual operating and capital budgets development and monitoring.
- Other duties as assigned.
- M.D. or Ph.D required
- Molecular Diagnostics: Five (5) years of medical laboratory experience required; two (2) of which must be in molecular diagnostics
- Molecular Diagnostics: Tennessee state license as a laboratory supervisor or laboratory director-General or Molecular Diagnostics required within first (six) 6 months of employment
- Director certification in Molecular Diagnostics, director certification as a Bioanalyst Clinical Laboratory Director (BCLD) or as a High-Complexity Laboratory Director (HCLD) from the American Board of Bioanalysis preferred
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