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Under the general supervision of Lab Management, the Lab Analyst II NENSP Molecular performs laboratory assays for the timely detection of newborn disorders. Maintains competency in high complexity testing (as defined by CLIA) in all molecular methodologies used in the section. Performs other related laboratory tasks in support of laboratory management. Responsibilities include careful adherence to established laboratory protocols, or specific directives of appropriate laboratory managers. This is an intermediate level laboratory position that requires previous relevant laboratory experience and will work under a moderate level of direction and supervision to perform assigned work.

Responsibilities

• Performs laboratory assays (clinical or research) with appropriate documentation, as an integral member of the section’s laboratory analysts, following validated protocols.
• Follows established safety and privacy protocols.
• Performs bench work to assist management in the performance and documentation of 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 bench work to assist management in laboratory activities for validation, troubleshooting the performance of and management of instrumentation used in the screening procedures.
• Performs bench work to assist management in laboratory activities for validation, troubleshooting and monitoring of the instrumentation relationships with Laboratory Information Management System.
• Works as an integral team member as needed in the preparation and validation of reagents, materials and kits used in the laboratory.
• Contributes data for laboratory documentation of quality assurance, quality control, and competency data in accordance with Program policies and CLIA requirements.
• Perform other duties as required.

REQUIRED EDUCATION
Bachelor’s degree or equivalent in chemical, life or clinical sciences
College-level coursework or equivalent yielding a solid understanding of the theory of molecular biology
REQUIRED WORK EXPERIENCE
1 – 5 years of relevant experience including some previous clinical laboratory experience
2 – 5 years of Assay Implementation and Troubleshooting experience
Experience with several of the following: Primer Design, Probe Design, LNA design, Multiplex RealTime PCR design, Nested PCR design, copy-number assay design in relation to
Experience in the clinical application of PCR-based assays, inclusive of the prevention and containment of amplicon contaminants
Experience in the 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)
Experience in the implementation of clinical assays for the evaluation of the presence/absence and quantification of molecular markers (RealTime and Digital Droplet PCR or equivalent).
2 – 5 years of Implementation of High-throughput Clinical Molecular Assays experience
Practical experience in the isolation of nucleic acids from small-volume (3 µL) dried blood spots or other similar human specimens.
Expertise in high-throughput processing of clinical specimens
Experience with robotics applications for high-throughput processing of clinical specimens
1 – 3 years of experience with specialized assays such as sequencing or human identity testing
1 – 3 years of experience in database and spreadsheet applications for quality monitoring
Must satisfy CLIA requirements for high complexity testing
Experience with standard concepts, practices, and procedures within the clinical laboratory
Good communication and organizational skills, with focus on detail and orderliness
Ability to perform laboratory procedures independently once trained, with great care and attention
Strong interpersonal skills
Experience with productivity software (Excel, Word, Access)
Flexibility in work schedule as required by laboratory section (i.e., weekend and holiday rotations).
PREFERRED WORK EXPERIENCE
Experience
Experience with standard concepts, practices, and procedures within the field of emerging technologic analyses
Experience in the development of PCR-based assays, inclusive of the prevention and containment of amplicon contaminants
Experience in the development 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)
Experience in the development of clinical assays for the evaluation of the presence/absence and quantification of molecular markers (RealTime and Digital Droplet PCR or equivalent).
Experience with Sanger sequencing and related informatics