IN-DOH-NGS Specialist

Molecular Biologist

This position is part of the Indiana Department of Health Laboratory, Advanced Molecular Detection Division. Incumbent is responsible for coordinating and performing the full range of molecular biological examinations and analyses, recording, interpreting, and result reporting of tests on specimens which may include human body fluids, tissues (human and animal), isolates from clinical specimens, and environmental samples to the submitting physician, clinic, hospital, or public health agency. Incumbent is also responsible for the development, validation, and implementation of new molecular tests, preparation of validation documents and SOPs, and troubleshooting of the existing molecular tests. Special emphasis for this position will be around genomic sequencing, maintenance of instrumentation for sequencing, and troubleshooting sequencing assays.

Incumbent will have in-depth knowledge and ability in the areas of molecular biology and is able to perform laboratory associated assays or the ability to learn these techniques upon successful completion of proficiency testing. Representative duties include:

• Extraction of nucleic acids from specimens, isolates, and samples via a variety of manual and automated methods;
• Utilize molecular techniques such as, but not limited to, PCR, MALDI-TOF, and NGS;
• Participate in the evaluation, development, validation, and implementation of new testing methods used in clinical/reference laboratory work, as well as, preparation of validation documents and SOPs;
• Provide technical oversight of the daily performance of high complexity testing; strictly following the laboratory's procedures for specimen handling and processing, test analyses, reporting, and maintaining records of test results;
• Maintain laboratory record system of submitted samples and specimens and their possible referral;
• Evaluate, interpret, validate laboratory results, and report findings;
• Conduct quality control checks on laboratory methods, materials, and equipment;
• Document all quality control activities, instrument calibrations, and maintenance performed;
• Participate in evaluation of new products used in clinical/reference laboratory work;
• Perform all related work as required.

Testing personnel responsibilities (42 CFR 493.1495 Standard): The testing personnel are responsible for specimen processing, test performance and for reporting test results. Each individual performing high complexity testing must— follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results; maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens; adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed; follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance; be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical supervisor, clinical consultant, or director; document all corrective actions taken when test systems deviate from the laboratory's established performance specifications; except as specified in paragraph (c) of this section, if qualified under § 493.1489(b)(5), perform high complexity testing only under the onsite, direct supervision of a general supervisor qualified under § 493.1461.

Job Requirements:

• Extensive knowledge of the principles, theories and practices of molecular biology, and related sub-specialties;
• Experience with Next Generation Sequencing platforms, technologies, and procedures.

Incumbent is engaged in scientific analyses that demand accuracy and demonstrated proficiency in applying laboratory analytical skills to select pertinent guidelines and formulated plans for problem solving. Projects involve many complex variables of great intricacy and the microbiologist is often called upon to analyze and identify unusual specimens/samples. Work requires considerable use of analytical judgement and technical knowledge in order to draw accurate, logical conclusions. Incumbent will also be required to develop and research new testing procedures. Responsibility: Incumbent works independently as an expert in the Biothreat laboratory. Technical and/or detailed instruction is provided only upon request when a procedural change and/or special project necessitates it. Incumbent maintains established safety practices when working with materials that have a chemical hazard or biohazard potential. Reports are reviewed for general technical accuracy; however, tasks are performed independently.

Skill - Required / Desired - Amount - of Experience

BA/BS in biological science. - Required

NGS (Next Generation Sequencing) experience using an Illumina Instrument or a PacBIO instrument. - Required - 1 - Years

2 years of high complexity laboratory experience as testing personnel, w/exp. providing oversight of daily performance of high complex testing - Required - 2 - Years

Extensive knowledge of the principles, theories and practices of microbiology and related sub-specialties; - Required

Specialized knowledge of current scientific methods and testing procedures and the ability to apply them when seeking solutions to public health lab. - Required

Specialized knowledge of/ability to use a full range of standard technical equip., complex scientific apparatus, and automated techniques of analysis - Required

Extensive knowledge of laboratory safety practices and principles; - Required

Aware of state and federal laws, rules, regulations, and policies concerning the program area (i.e. CLIA); - Required

Ability to effectively communicate technical information both verbally and in writing and maintain productive working relationships; - Required

Ability to satisfactorily participate in proficiency testing programs; - Required

Ability to compile, analyze, evaluate, and prepare laboratory reports. - Required