lllumina’s Clinical Laboratory is currently recruiting an Associate Laboratory Director who will oversee clinical whole genome sequencing testing for patients with rare and undiagnosed genetic disease. Illumina's clinical whole genome sequencing test is designed to detect and report on single nucleotide variants (SNVs), small insertion/deletion events, copy number variants (CNVs), homozygous loss of SMN1, mitochondrial SNVs, and short tandem repeat (STR) expansions occurring at sites with associations with genetic disease. The Associate Laboratory Director will join a leading team of clinical genetics professionals, scientists and bioinformaticians to conduct clinical whole genome sequencing testing and continue to develop and validate new features of the test. The Associate Laboratory Director will work closely with a team of Clinical Genomics Scientists and Genetic Counselors on the interpretation and reporting of whole genome sequencing data for patients tested, as well as with teams across all clinical laboratory functions including accessioning, customer support, wet laboratory, bioinformatics and quality assurance. In addition, the Associate Laboratory Director will support and oversee clinical laboratory validations including the addition of new variant types to the test as well as software features to support case interpretation and reporting.
Roles and responsibilities include supporting the Sr. Laboratory Director in ensuring the accuracy and responsibility of all testing performed by the laboratory and for ensuring that the laboratory meets all applicable CLIA and state requirements as stipulated in both federal and California laws (Code of Federal Regulations [CFR], Title 42, Sections 493.1407, 493.1445; California Business and Professions Code [BPC], Section 1209).
This is a full time role based in San Diego, California, with a specific focus on clinical whole genome sequencing, including (but not limited to) rare genetic disease applications.
At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact email@example.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
Job Responsibilities include but are not limited to:
Clinical interpretation of WGS test results as well as direct interpretation of reports and patient results to ordering physicians as needed.
Ensure test reports provide pertinent information required for interpretation and consultation is available to laboratory clients concerning reported test results.
Provides laboratory testing knowledge to internal teams.
Ensures that newly developed assays and components of the clinical whole genome sequencing test are properly validated in a CLIA/CAP/NY State compliant environment.
Reviews and recommends improvements for laboratory procedures based on quality metrics and test results over time.
Ensures processes and services are monitored for quality through continuous process and quality improvement. Recommends and implement ideas to improve operational efficiency.
Ensures services are provided in accordance with state and federal regulations, lab policy, and accreditation and compliance requirements in conjunction with the Sr. Laboratory Director. Provide guidance to laboratory staff as required by applicable state and federal regulations.
Maintains current professional and best practice knowledge. Completes required continuous training and education, including department specific requirements.
Ensure test systems have established acceptable performance specifications for the characteristics of accuracy, precision, analytical sensitivity, and analytical specificity.
Ensure policies and procedures are established to monitor, assess, and identify problems with analytical test methods, and when indicated that remedial and corrective actions are taken and documented.
Supports on-site supervision of high complexity test performance by testing personnel and that qualified personnel perform delegated responsibilities.
Supports laboratory policies and procedures that are established for hiring and monitoring individuals who conduct pre-analytic, analytic, and post-analytic phases of testing to assure they have the appropriate education and experience, are competent and maintain their competency to perform the testing procedures.
Supports the laboratory’s established Proficiency Testing (PT) program.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Education and Experience:
Board-certified in clinical molecular genetics by the American Board of Genetics and Genomics (ABMGG) or Laboratory Genetics and Genomics (LGG)
Preferred experiential background:
Board-certified in clinical cytogenetics preferred
New York State Certificate of Qualification in Molecular Genetics preferred
Proven experience with next-generation DNA sequencing for medical genetics diagnostic testing
Basic competency in statistical analysis
Knowledge of regulatory requirements for molecular diagnostic laboratory developed tests from product development to commercialization through post launch support
Analytical and strong problem solving skills
Strong written and oral communication skills
Ability to collaboratively work in a dynamic, fast-paced work environment
Telecommuting is allowed.
Internal Number: 23496-JOB
About Illumina, Inc.
At Illumina, our goal is to apply innovative technologies and revolutionary assays to the analysis of genetic variation and function, making studies possible that were not even imaginable just a few years ago. These studies will help make the realization of personalized medicine possible. With such rapid advances in technology taking place, it is mission critical to have solutions that are not only innovative, but flexible, scalable, and complete with industry-leading support and service. As a global company that places high value on collaborative interactions, rapid delivery of solutions, and prioritizing the needs of its customers, we strive to meet this challenge. Illumina’s innovative, array-based solutions for DNA, RNA, and protein analysis serve as tools for disease research, drug development, and the development of molecular tests in the clinic.
We have roughly around 9,500 employees (Full-time and contract).