As the Lab Director, you are responsible for directing overall function of the Fulgent Laboratory. The Director must have acquired and maintained ABMG Board certification. This position requires management skills that allow direct and indirect supervision to the laboratory staff, and operation of the laboratory. He/she must be familiar and experienced in CAP, CLIA, New York/California State and both Federal regulations and certification standards, as well as be responsible for ensuring full compliance to all relevant laws and regulations. Other essential functions include:
Accountability of all aspects of the laboratory service, and serves as the key bridge between laboratory operations and clinical practice.
Planning, organizing and directing the overall operation of the Laboratory Department. This involves overseeing all aspects of genetic testing performed in the laboratory (from sample receipt to reporting) to obtain accurate data for use in diagnosis and treatment of diseases.
Ensure that services are of the best quality, are cost contained and are carried out in an expeditious manner to ensure customer satisfactions.
Key Job Elements:
Supervises and oversees all operations and administration of the lab.
Retains delegation authority, retention of responsibilities and accountability. Maintains laboratory license & accreditation such as implementing and maintaining CAP & CLIA standards compliance.
Approves Job descriptions of all clinical staff and oversee hiring standards (may also be involved in staff selection). The responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the pre-analytic, analytic, and post-analytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results.
Employs a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described.
Delegation and assignment of duties for technical supervisor, technical consultant, clinical consultant, general supervisor, and testing personnel (any of which are relevant).
Retains responsibility that delegated tasks are performed to an acceptable standard to assure quality patient services are provided.
Oversees training and competency standards & assessments (including conducting of staff performance reviews).
Ensures that the physical and environmental conditions of the laboratory are appropriate for the testing performed and a safe environment in which employees are protected from physical, chemical and biological hazards
Ensures that a general supervisor provides onsite supervision of high complexity test performance by qualified testing personnel
Testing Procedures/Lab Operations
Provides oversights for robust development and validation of lab-developed tests prior to clinical testing to ensure patient safety.
Oversees the Quality Management Program.
Oversees specimen acceptance/rejection and test ordering process (includes specimen handling & retention).
Oversees all standard operation procedures: lab operations, bioinformatics analysis & results curation/reporting.
Ensures effectiveness of quality program and its standards.
Ensures compliance of proficiency testing performance (external and internal).
Ensures that an approved procedure manual is available to all personnel. Ensure effective corrective and preventive actions for all non-conformances.
Consultation & Staff Education
Maintains accessibility and availability to laboratory staff for decision approval.
Provides guidance and supervision in results interpretation, therapeutic recommendations (if applicable), troubleshooting, and test menu changes.
Oversees compliance for continuing education requirements (as necessary).
Functions as the clinical consultant to provide consultation and education to physicians/clients, patients and genetic counselors.
Oversees and facilitates (where necessary) communication within the administration and among laboratory staff.
Mediates communication with accreditation or certification bodies.
Overall Operations Management
Strategizes growth plan to ensure technology and scientific growth which aligned with the approved budget for operations, Research and Development.
Approval of contracting & marketing materials.
Directs organizational goals and assessment of operational metrics.
Provides effective and efficient administrative direction of the laboratory, including budget planning and controls in conjunction with the individual(s) responsible for financial management of the laboratory.
Knowledge and Experience:
Have earned a Ph.D. degree in molecular biology, genetics, or M.D. degree.
Must have acquired and maintained ABMG Board Certification.
Maintain California State certified licensing for clinical testing (CLS/CGMBS).
Good standing Lab Director Certificate of Qualification issued by the State of New York Department of Health is preferred.
7 or more years of experience in a clinical setting with hands-on involvement in molecular/genetics testing is preferred.
Must have great work ethic and immaculate attention to detail.
Knowledge of molecular biology and/or medical genetics in a clinical setting.
Ability to demonstrate skills in next generation sequencing assay.
Ability to demonstrate skills in assay development.
Experience with microarray platforms for biomarker and pathway identifications.
Safety and Work Environment:
General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Maintains a clean, neat, and orderly work area.
Adheres to Department Specific Safety Guidelines.
Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 10 pounds.
Must pass a color vision test if responsibilities require color discrimination.
Additional Salary Information: This is a full-time position. Fulgent Genetics offers competitive compensation and benefits package which includes but not limited to salary, health insurance, life insurance, dental insurance, 401(K), profit sharing and continue education program.
Internal Number: LAB 040119-0001
About Fulgent Genetics
Fulgent is a leader in genetic and genomic clinical testing, a publicly traded company located in Los Angeles, California. We are a technology-driven company with extensive academic/clinical experience and capabilities in Next Generation Sequencing and bioinformatics. This distinction has advanced us to the forefront of the rapidly advancing genetic and genomic testing industry.
Fulgent's unique chemistries and superior proprietary bioinformatics pipeline has propelled our explosive growth in recent years. We offer the most expansive set of clinical genetic tests in the world, including 22,000+ single gene tests, 900+ preset panels, rearrangement testing, clinical exome/trios, whole exome/trios, whole genome and our All-in-One reflex test. We are a CLIA and CAP accredited laboratory. Fulgent has state-of-the-art clinical, sequencing and bioinformatics tools, including the latest Illumina sequencers such as the NovaSeq.