Laboratory Director - Curation - #176298

About Fulgent

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 have 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.

Summary

SUMMARY OF POSITION:

The Lab Director, Curation is responsible for directing the overall function of the Fulgent Curation Department, including direct supervision of employees, sign-out of molecular genetics test results, and leadership in research & development. This position requires management skills that allow direct and indirect supervision of the curation scientist team to ensure our continuous quality and integrity and efficiency of the curation process. Must be familiar and experienced in CAP, CLIA, and State and Federal regulations and certification standards and be responsible for ensuring full compliance with governing regulations. Due to the nature of our current test menu, significant experience with Next Generation Sequencing in the context of molecular diagnostics is required.

Key Job Elements

• Final report sign-out of our patient reports.
• Provide leadership to the Operations, R&D, and Product Development teams in the areas of clinical and analytical validity.
• Lead curation team to work with research scientists and bioinformaticians on product development efforts.
• Collaborate with the software engineering team to design, optimize, and automate QC and data review interfaces.
• Design assay validation studies.
• Partner with the quality management team to develop, implement and maintain SOPs and appropriate quality control and regulatory compliance programs.
• Work with technical supervisors to improve procedures for sequencing QC and data review, review sequencing quality indicators on a weekly basis, and help develop action plans.
• Refine curation protocols and classification criteria.
• Review variant classifications and final reports.
• Function as a knowledge resource for difficult cases.
• Develop new products in conjunction with the Genetic Counseling, Business Development, Sales, and Marketing teams.
• Assist with research, development, and grant applications with various teams including Business Development, Sequencing as a Service, and Research & Development.
• Be an ambassador to the genetics community, including giving public lectures, attending major conferences, and interacting with client providers such as physicians and Genetic Counselors.
• Author/co-author peer-reviewed scientific manuscripts.
  
  

Qualifications

KNOWLEDGE / EXPERIENCE:

• Have earned a Ph.D. degree in molecular biology, genetics, or a related field or an M.D. with residency in Anatomic and/or Clinical Pathology (USA/Canada). Sufficient previous work history in the listed fields may substitute educational requirements.
• ABMGG board-certified clinical molecular geneticist or ABP board-certified molecular genetic pathologist.
• Required Experience with: (1) Interpreting variants in the context of the medical literature (experience with germline diagnostics including hereditary cancer syndromes or exome sequencing desired), (2) Corresponding with medical geneticists and oncologists on the interpretation of results, (3) Design of gene panels and molecular tests, (4) Reviewing results of germline and/or somatic NGS assays for validity, (5) CLIA lab operations and testing requirements.
• Comfortable in a fast-paced, dynamic team environment.
• Excellent leadership, human relations, and communication skills.
• Requires high attention to detail and the ability to multi-task and adapt rapidly to changing priorities and tasks.
  
  

Supervisory Responsibilities

• Yes
  
  

Reports To

• Managing Lab Director
  
  

Environment

Fulgent Therapeutics LLC is an Equal Employment Opportunity Employer.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions. The term “qualified individual with a disability” means an individual with a disability who, with or without reasonable accommodation, can perform the essential functions of the position.

For California residents, please see the link below to access our CCPA Privacy Notice.

CCPA Privacy Notice for California Residents

https://tinyurl.com/FulgentCCPA