Under the general direction of Lab Management, the Lab Analyst III NENSP Molecular performs laboratory assays for the timely detection of newborn disorders and works on special projects to develop, implement and evaluate new methodologies to improve current screening, and add new capabilities. Maintains competency in high complexity testing (as defined by CLIA) in all laboratory methodologies of the section. Performs other related laboratory tasks in support of laboratory management. Responsibilities include careful adherence to established laboratory protocols, as well as projects under the direction of laboratory managers. Performs work with little, or sometimes no direct supervision and is expected to train more junior staff. Works with Lab Management on design providing the first line of bench strength for the development of emerging technologies

• 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 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.
• Responsible for training junior lab analysts.
• Works independently on assigned laboratory projects to develop and validate data and new methodologies.
• Works independently to draft documents including new SOPs.
• Assists the Lab Supervisor and Scientist with the management of lab supply budget and inventory
• Perform other duties as required.

REQUIRED EDUCATION

Bachelor’s degree or equivalent in chemical, life or clinical sciences

Graduate level coursework or equivalent yielding expertise in the theory of general molecular biology

REQUIRED WORK EXPERIENCE

5 – 7 years of relevant experience including 1 – 2 years clinical laboratory experience

5 – 7 years of Assay Design, Implementation and Troubleshooting experience

Experience in Primer Design, Probe Design, LNA design, Multiplex RealTime PCR design, Nested PCR design, copy-number assay design such that the analyst has established expertise 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 Implementation of High-throughput Clinical Molecular Assays experience

• Expert-level 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

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 experience with specialized sequencing assays for detection of allele dropout

1 – 2 years of experience with specialized assays and related informatics for human identity testing

1 – 2 years of experience with NextGen Sequencing theory to assist staff scientist with implementation.

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

Experience and/or training in clinical/medicinal chemistry, emerging clinical analytic technologies

Strong communication and organizational skills, with focus on detail

Ability to perform laboratory procedures independently with great care and attention

Interpersonal skills in independent as well as team work

Experience with productivity software (Excel, Access, Word,)

Flexibility in work schedule as required by laboratory section (i.e., weekend and holiday rotations).  

PREFERRED EDUCATION

Master's Level Degree in chemical, life or clinical sciences

PREFERRED WORK EXPERIENCE

Experience with standard concepts, practices, and procedures within the field of emerging technologic analyses

Familiar with the use of bioinformatic computing technology in new assay design, management and analysis of data, and research of relevant scientific literature.