MolecularMicrobiologist_Bethesda_Maryland

We are currently looking for a Molecular Microbiologist for a multi-year contract position with Walter Reed Medical Center in Bethesda, MD. 

The Molecular Microbiologist coordinates and conducts all pre-analytical, analytical and post-analytical aspects of complex technical work involved in preparing and interpreting human biological material for specialized molecular genetic analysis. Work involves development, verification, validation and testing molecular sequencing systems and applies broad knowledge and hands-on experience in such disciplines as molecular biology, molecular pathology and biostatistics.  Skill and experience in next-generation sequencing (NGS) platforms is required.  Also, as per DoD Clinical Laboratory Improvement Program requirements, MB(ASCP) or SMB(ASCP) certification is required for this position. The position requires experience and demonstrates capability in standard molecular biological techniques, e.g., isolation of nucleic acids from various clinical specimens (blood, body fluids and tissue), polymerase chain reaction (PCR) as well as standard biochemical techniques, e.g., centrifugation and gel electrophoresis. Knowledge and skills for implementation of a completely electronic format for collecting, reporting and storage of laboratory data using Laboratory Information Management System (LIMS) is critical.

The individual will provide the following support:

1. Coordinates and conducts all aspects of molecular testing focusing on nucleic acid (DNA/RNA) extraction, polymerase chain reaction (PCR) and Next Generation Sequencing (NGS) assays.
   
1. Oversees all pre-analytical factors involved in specimen submission for both in-house and remote contributors. This includes test verification and validation to determine the exact indications, analytical sensitivity and specificity, clinical sensitivity and specificity, and utility of the assays being offered. It also includes the establishment of specimen requirements, establishment of specimen rejection criterion, authoring a specimen submission manual, distribution of the specimen manual, and communication with contributing providers.
   
2. Specimen processing is conducted using a combination of manual and automated processing methods. Vendor-specific training is required for the multiple automated processors used in the molecular laboratory. The incumbent will process the specimens to ensure the maintenance of specimen identification throughout the many processing steps. Specimens are handled in accordance with the specific conditions required to maintain specimen integrity and preservation. Technical trouble shooting will be performed to ensure specimens are ready for interpretation in a timely manner and that specimen quality remains high.
   
3. Will correctly process specimens by extracting DNA, amplifying genomic regions of interest with PCR and performing NGS.  All available clinical information will be used to arrive at the correct diagnosis, including the review of the provided clinical history.  When indicated, direct communication with the contributor may be required to correlate the molecular testing indications with the clinical situation, in order to arrive at the correct diagnosis. The incumbent will properly maintain the NGS systems by ensuring that proper maintenance and repairs occur.
   
4. Plans and conducts procedures to devise solutions to testing problems and to evaluate published methods and techniques for incorporation into the molecular pathology laboratory. They participate in research protocols, develop research methods, and prepare data for publication in professional journals. The incumbent coordinates the procurement of supplies, equipment and instrumentation within budgetary limits and coordinates preventive maintenance programs.
   

2. Quality assurance indicators must be closely monitored to provide any early indications of problems that may adversely affect the accuracy of the test results. The incumbent will monitor quality assurance metrics throughout the pre-analytical, analytical and post-analytical phases of testing to evaluate trends in specimen quality, specimen processing, specimen evaluation and specimen reporting, so as to provide an early indication of problems that may adversely affect the accuracy of the test results.
   

a.   Provides technical expertise to coordinate the quality control program for the Molecular Pathology Service and insures participation in acceptable proficiency testing programs. They evaluate the quality of laboratory services and processes, the adequacy of equipment, personnel and working accommodations through onsite inspections, audits, and review of reports. They assess laboratory needs and explore methods to obtain resources and implement improvement programs. The incumbent is responsible for assuring compliance with quality control and proficiency testing programs, safety requirements, and standards set by accrediting and regulatory agencies.

3. Will design the laboratory to function in full accordance with accreditation standards established by the College of American Pathologists (CAP) and the DoD Clinical Laboratory Improvement Program (CLIP). This involves regular monitoring of CAP and CLIP accreditation requirements to make sure the laboratory’s procedures and practices are in compliance with all accreditation standards. The incumbent is responsible for monitoring trends and medical breakthroughs that may apply to routine clinical practice and then incorporating those discoveries into the lab at the instruction of the Medical Director.
   
4. Identifies training needs and arranges or conducts in-service training. They provide technical guidance, instruction, and consultation to faculty, students, and house-staff members (interns and residents) as assigned to include training of new personnel.  Under the guidance of the Pathology Residency Program Director, the incumbent contributes to the curriculum and develops assessment tools while adapting current education philosophy techniques into the program of instruction.  The incumbent is personally responsible for attaining and maintaining all relevant technical competencies and certifications to meet the standards for molecular technologists as outlined by the College of American Pathologists (CAP) and the DoD Clinical Laboratory Improvement Program (CLIP).
   

5. Performs complex and highly exacting technical work that involves preparing human biological material for specialized molecular genetic analysis. Molecular testing requires strict adherence to, and development of, methods to prevent cross-contamination of DNA/RNA from the environment and other specimens that could result in an erroneous diagnosis of a genetic abnormality. The molecular technologist assesses new instruments for implementation and may develop or modify procedures for new molecular tests that may or may not have Food and Drug Administration (FDA) approval. In developing new tests, they analyze and correct errors resulting in spurious or unacceptable test results prior to implementation.
   
1. Operates complex computerized equipment to analyze prepared biologic specimens, to calibrate instrumentation, and to validate quality of assays. The incumbent is required to develop procedures and processes for tests and to modify existing procedures to improve the quality of results. The incumbent compiles, analyzes, and documents procedures performed.
   
2. Develops or assists in the development of clinical assays and the validation of those assays including performance of testing or analysis and written documentation of recommendations. They will research and investigate new biomarkers emerging in the molecular community and establish new testing methodologies for the laboratory. They will coordinate with outside reference laboratories to establish parameters for the selected analytes that will reflect the accrediting agency guidelines. The incumbent will document and standardize the protocols for the establishment of the testing in the triage of patient care. They will continue to maintain appropriate documentation of initial and ongoing validations in compliance with internal and external regulatory agencies.
   
3. Reviews clinical reports and records for trends and recommend policy changes based on review findings. They establish and maintain contacts with other Federal and State agencies, accrediting organizations, professional organizations and other agencies to keep abreast of new developments, obtain services and coordinate mutually beneficial projects. The incumbent maintains technical expertise and serves as a technical consultant for the Molecular Pathology service. They interpret agency policies and directives, prepare guidelines for laboratory operations, and advise the Medical Director on the maintenance, review and revision of procedure manuals.
   
6. Performs all other duties within the molecular laboratory as assigned.
   

Job Specifications / Qualifications:

Required Knowledge, Skills, and Abilities: 

• Must be certified by the ASCP, AMT or other organization deemed comparable by OASD(HA) or their designee Center for Laboratory Medicine Services (CLMS) as an MLT or MT/MLS.
  
• Knowledge of basic computer programs; ability to follow detailed instructions; good written and verbal communication, organizational, and analytical skills.
  

Minimum Education/Training Requirements: 

• A BS degree in Biological Science or related field is preferred.
  

Minimum Experience:

• 1-2 years of experience in sequencing and mutation analysis in a molecular pathology service laboratory is required.  Knowledge and work experience with next generation sequencing techniques (Illumina) including basic bioinformatics knowledge is very desirable.
  

Required Licenses, Certification or Registration: 

• MB(ASCP) or SMB(ASCP) or other certification deemed comparable by OASDHA or their designee (CCLM)
  

Physical Capabilities: 

• Long periods of standing and sitting.
  

Work Environment: 

• Laboratory environment.
  

Must be a US Citizen and pass a favorable National Agency Check.