Layer, Chiang, et al. Genome Biology
Position Code: 12-PD-058
Reports To: Vice President, Operations
The Lab Director is responsible for providing overall direction and management of Complete Genomics’ laboratory operations. This includes ensuring the quality of data provided, compliance to CLIA/CAP and other related requirements, and building the appropriate organization to meet business requirements.
• Providing direction and leadership to employees in the labs
• Working with cross-functional teams to ensure that our Quality Management System (QMS) is developed and implemented for all phases of testing, to include the pre-analytic, analytic and post-analytic phases of testing as well as general lab systems
• Ensuring test systems have established acceptable performance specifications for the performance characteristics of accuracy, precision, analytical sensitivity, and analytical specificity of the system, to include performance, maintenance and calibration of instrumentation and equipment used to perform the testing.
• Ensuring policies and procedures are established to monitor processes; and when indicated, remediate, take corrective actions and document when problems are identified with the analytical test methods.
• Ensuring policies and procedures are established for hiring, training and monitoring people 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.
• Ensuring the labs have established approved Proficiency Testing (PT) programs to include an approved corrective action plan when any PT results are determined to be unacceptable.
• Managing a complex process spanning molecular biology, surface chemistry, and DNA sequencing in high volume biochemistry operations, including automated processes and complex, multistep chemistry in a dynamic environment.
• Providing strong leadership in cross functional teams.
• Plans and administers directly and through supervisory personnel the effective delivery of whole genome sequencing data in accordance with all regulatory agency standards.
• Oversees the development and maintenance of quality control programs necessary to ensure all procedures are performed properly and that the results are valid and accurate prior to release.
• Required Certificates, Licenses, Registrations:
The laboratory director must be currently licensed as a Laboratory Director by the State of California (BPC 1209) and meet the qualifications for Laboratory Director as specified by CLIA regulations for high complexity testing (42CFR, part 493).
• Certificate of Qualification in Molecular Genetics.
• A minimum of five years of experience leading relevant laboratory operations
• Experience in leading laboratory operations through early qualification and validation process
• Demonstrated ability to develop staff and organization
• Strong interpersonal and leadership skills
• Excellent written and verbal communication skills, demonstrated ability to collaborate within interdisciplinary teams
Preferred educational background:
• California licensed doctor of medicine or doctor of osteopathy. Certified in anatomic or clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology, or at least one year of laboratory training during medical residency or at least two years of experience directing or supervising high complexity testing or hold a doctoral degree in chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS.
Please apply to our Career page at www.completegenomics.com
Complete Genomics provides academic and biopharmaceutical researchers with complete human genomic data and analysis at an unprecedented quality, cost and scale without requiring them to invest in in-house sequencing instruments, high-performance computing resources and specialized personnel.
Complete Genomics Analysis Platform, or CGA™ Platform, combines our proprietary human genome sequencing technology with our advanced informatics and data management software and our innovative, end-to-end, outsourced service model to provide our customers with data that is immediately ready to be used for genome-based research. Our solution broadly enables researchers to conduct large-scale complete human genome studies.
We are looking for people who thrive in a challenging, fast-paced environment, who are team oriented, self-motivated, and committed to contributing to the success of our company.