Under the general direction of the Senior Scientist or designee, the Supervisor is responsible for all of the day-to-day technical and administrative activities of the molecular laboratory within the newborn screening program. Supervises all technical processes related to the molecular laboratory's testing of newborns, from specimen receipt through analysis with validated protocols and documentation of testing. Develops, evaluates and implements new DNA- or RNA-based methodologies to improve current screening, as well as add new capabilities. Implements quality assurance and safety activities inclusive of written protocols, selection of appropriate equipment and instrumentation, LIMS relationships, employee training, competency assessment, operations improvement, and proficiency testing. Serves as a significant expertise resource to the Newborn Screening Program (bringing new information and technology into the Program from outside sources, by reading and evaluating literature, and networking with colleagues), and independently contribute to development of molecular technologies applicable to our high throughput screening services.

• Oversees the scheduling and work activities of all Laboratory Analyst staff in a manner that ensures accurate and timely clinical testing and reporting.
• Oversees the instruction of all molecular-laboratory analyst staff, ensuring a diversity of competencies in molecular genetic theory, practice, assay development and expertise in the programming and application of the robotics necessary to accomplish daily work.
• Performs (under the guidance of the scientist), supervises and documents laboratory activities for the technical development, validation, performance and troubleshooting of laboratory assays (both laboratory-developed tests as well as kit assays) used in the screening procedures.
• Performs (with or without assistance from the scientist), supervises and documents laboratory activities for the validation, troubleshooting the performance of and management of instrumentation used in the screening procedures.
• Performs (with or without assistance from the scientist), supervises and documents laboratory activities for the validation, troubleshooting and monitoring of the instrumentation relationships with the Laboratory Information Management System.
• Maintains laboratory documentation of quality assurance, quality control, and competency data in accordance with Program policies and CLIA requirements.
• Maintains and implements written policies and standard operating procedures approved by the scientist.
• Participates in the establishment of, and follows safety, privacy and compliance protocols relevant to the laboratory section.
• Ensures that laboratory analysts are compliant with established safety, privacy and compliance protocols relevant to the laboratory section.
• Performs laboratory assays (clinical or research) with appropriate documentation, as an integral member of the section’s laboratory analysts, following validated protocols.
• Manages lab supply budget and inventory, and assists the Scientist in the preparation and validation of reagents, materials and kits used in the laboratory.
• Reviews literature and recommends improvements to test interpretations and methodologies for use in the laboratories.
• Makes independent contributions to the development and implementation of new testing capabilities.
• Participates (under the guidance of the scientist) in the research and development of new methodologies.
• Makes significant contributions to the writing of publications, presentations, and other means of disseminating knowledge gained from screening operations in the laboratory section.
• Perform other duties as required.

REQUIRED EDUCATION
Master’s degree in chemical, life or clinical sciences; or equivalent
Graduate-level coursework yielding expertise in the theory of general molecular biology

REQUIRED WORK EXPERIENCE
5 – 7 years of relevant experience including at least 1-2 years in a clinical laboratory
5 – 7 years of Assay Design, Implementation and Troubleshooting
In-depth experience and expertise in Primer Design, Probe Design, LNA design, Multiplex RealTime PCR design, Nested PCR design, copy-number assay design such that the supervisor is a recognized expert in the following:
• clinical development and application of PCR-based assays, inclusive of the prevention and containment of amplicon contaminants,
• the development and implementation of clinical detection systems for the generation of human genotypic data using a variety of techniques (Luminex Lab developed tests, Real-Time lab developed tests), and
• the development and implementation of clinical assays for the evaluation of the presence/absence and quantification of molecular markers (RealTime and Digital Droplet PCR or equivalent), such that the development yields low-cost laboratory developed tests.

5 – 7 years of Development of High-throughput Clinical Molecular Assays
• Expert-level practical experience in the isolation of nucleic acids from small-volume (3 µL) dried blood spots or other similar human specimens.
• Expert-level practical experience with high-throughput processing of clinical specimens (e.g. integrated flow chart development)
• Expert -level practical experience with robotics programming for high-throughput processing of clinical specimens
3 – 5 years of experience with BLAST and gene homology tools available through NIH and commercial vendors
3 – 5 years of experience with database and spreadsheet tools for use with quality monitoring and data management
3 – 5 years of experience with Sanger sequencing and related informatics
1 – 2 years of sufficient familiarity with Next Gen Sequencing theory to maximize efficiencies of high-throughput screening assays to be interfaced with NextGen sequencing.

Must satisfy CLIA requirements for high complexity testing
Skilled in the knowledge, performance, and interpretation of lab tests and techniques
Skilled in computer file management and general software usage
Communications and writing skills for scientific reports, oral presentations, SOPs, internal communications
Skilled in clear communications and maintenance of good working relationships with co-workers
Flexibility in work schedule as required by laboratory section (i.e. weekend and holiday rotations).

PREFERRED WORK EXPERIENCE
Previous supervisory experience
A thorough understanding of regulatory issues (e.g. CLIA, OSHA) as they apply to clinical laboratory testing
Practical knowledge of human molecular genetics