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Details
Posted: 13-Mar-23
Location: San Diego, California
Type: Full Time
Categories:
Academic / Research
Sector:
Life Science & Biopharmaceutical Companies
Internal Number: 2023P-0206
Summary:
At Bionano we are committed to transforming the way the world sees the genome. Our optical genome mapping platform and analysis tools can be used to detect a wide range of structural variants to see the true genome structure to fill in what is missing from sequencing-based data.
Bionano Laboratories, the RUO and CLIA/CAP services business unit of Bionano, is looking for an on-site board-certified (ABMGG) laboratory director that currently holds or is eligible for California laboratory director licensure. The clinical laboratory operations director will be responsible for the ongoing performance and day-to-day operations of the RUO and CLIA/CAP laboratory operations including the implementation and oversight of proficiency testing, quality control and quality improvement programs. This individual will also be involved with the sign out of cytogenetic and molecular testing in accordance with CA State, CLIA and CAP regulations. Finally, Individuals in this position will work closely with senior management to evaluate novel technologies and provide technical expertise on existing platforms.
Areas of Responsibility:
- Accountable for the overall operation and administration of a clinical laboratory site, including compliance with the applicable regulations, competence of lab personnel performing testing, and accuracy and timeliness of results to deliver excellent patient care and to support business needs.
- Monitor capacity necessary to handle current and projected workloads and recommends and monitors implementation of necessary staffing, facilities, and equipment enhancements.
- Strives to streamline operations and effectively apply new concepts and techniques for positive outcomes; identifies and implements technology to improve operations.
- Ensure laboratory compliance with all international, US federal, and US state laws and regulations that govern the laboratory’s operations (CLIA, NYS, and other state laboratory standards).
- Responsible for the review and approval of various critical documentation, policies and reports, oversight of clinical testing strategies, assay(s) performance monitoring, and approving validations and verifications of new assays and assay modifications.
- Performs professional interpretation & completion (sign-out) of clinical LDTs offered by the laboratory, including: optical genome mapping, microarray and/or NGS with use of clinical and phenotypic information.
- Responsible for attending all weekly and biweekly meetings required for the performance and improvement of the laboratory.
- Responsible for maintaining licensure and continuing education requirements, i.e. attending educational webinars for gaining new and additional expertise in areas of interest for the Company. Responsible for attending at least one educational conference a year for maintaining CMEs and increasing knowledge about advancements in the field of genetics.
- Responsible for collaborating with other clinical and research staff for the purpose of publishing high quality peer-reviewed research data.
- Responsible for ensuring that all HIPAA regulations and company policies are strictly adhered to.
- Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures.
- Responsible for performing additional related duties as assigned.
Qualifications and Requirements:
Education/Certification/Experience:
- Requires an M. D. or Ph.D. or M.D./Ph.D or equivalent in pathology, molecular genetics, or related field.
- Requires board certification (or eligibility for board certification) in Laboratory Genetics and Genomics (LGG), or Clinical Cytogenetics and Molecular Genetics, or Molecular Pathology by the American Board of Medical Genetics (ABMGG).
- Cytogenetics experience (cancer and constitutional) strongly preferred.
- Requires eligibility for California laboratory director license (active California laboratory director license or license to practice medicine in the State of California preferred).
Skills/Knowledge/Abilities:
- Thorough knowledge of ISCN guidelines and molecular cytogenetics nomenclature with excellent detail-oriented work habits.
- Demonstrated deep and broad knowledge of medical genetics.
- Knowledge of ACMG variant classification and interpretation of molecular sequencing data/results.
- Excellent interpersonal and management skills, including proven management, presentation, negotiation and team facilitation.
- Excellent written and oral communication skills with ability to tailor, translate, and communicate complex information in a relevant manner for a broad range of audiences.
- Ability to adapt to a fast-paced clinical environment in which priority cases or other critical work may arise without warning and still provide excellent and high-quality clinical reports.
- Good computer skills with proficiency in Microsoft Office Products (Word and Excel).
- Ability to learn and grasp new computer programs and internal procedures.
Problem Solving:
- Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
- Seeks out all resources when selecting methods and techniques for obtaining results.
- Acts independently and proactively to direct method and procedure for problem resolution.
- May travel up to 10-20% of the time.
About Bionano
At Bionano, we are committed to unlocking understanding of genome biology to advance the promise of genomics in areas including cancer and human disease, agricultural bioengineering and genome discovery. Our optical genome mapping and analysis tools help researchers see true genome structure to fill in what’s missing from sequencing-based data.
At Bionano, we are invested in the success of our customers and users around the world, and are dedicated to supporting them with the tools, resources and support they need to achieve their goals and make a real impact on improving quality of life for all.
https://careers.ashg.org/jobs/18319156/clinical-laboratory-director
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