Assay Development Manager Jobs in Gaithersburg, MD

Position Objective: The Biologist will independently provide support services to satisfy the overall operational objectives of the NIH Clinical Center, Department of Transfusion Medicine, Human Leukocyte Antigen Laboratory within the National Institutes of Health.

Duties and Responsibilities:

• Perform work in the DTM HLA Laboratory, including the following major laboratory procedures: 1
• Perform specimen processing 2
• DNA extraction and quantitation utilizing various manual and automated methods 3
• Molecular HLA typing utilizing polymerase chain reaction PCR, sequence specific primer SSP, sequence specific oligonucleotide SSO technology, and sequenced based typing SBT
• Molecular HLA typing utilizing next generation sequencing
• Next generation sequencing data analysis
• Agarose preparation and gel electrophoresis; photo-documentation of results
• Interpretation of all HLA typing results
• Support the general HLA staff in communication with transplant groups and appropriate documentation
• Perform troubleshooting on current HLA analysis software and database management systems and all facets of laboratory
• Various HLA antibody screening and identification methods and interpretation
• Work with staff on the identification of unusual HLA antibody and typing patterns; maintain leadership and support role to encourage staff members to understand the complexities of antibody identification and the other work they perform
• Perform final review analysis process and determine any discrepancies which need resolution
• Participate in the review and audit of laboratory records and standard operating procedures SOPs in order to improve the efficiency and effectiveness of the laboratory; maintain related documents
• Participate in the review of QC and quality assurance records to assure that the laboratory is maintaining necessary levels of accreditation
• Maintain documents related to keeping maintenance documentation and monitoring of quality assurance practices
• Provide a leadership role in taking the initiative to implement changes upon request
• Work with staff on test assay development, validation and implementation of new equipment and reagents in the sequencing area in order to provide a more efficient high-throughput test; maintain related documents
• Collaborate with staff on the evaluation of any new reagents assays for antibody detection that may benefit the laboratory
• Perform validation and recording of specimens in all appropriate software-based applications
• Apply troubleshooting skills in the areas of the laboratory software applications and instrumentation
• Monitor the quality assurance practices in all aspects of laboratory work
• Coordinate the teaching process of fellows, students, and other laboratory staff regarding new procedures and techniques
• Work on various research projects through the laboratory in order to document potential clinical application in the laboratory
• Work products and documents related to performing work in the DTM HLA Laboratory, including specimen processing, DNA extraction and quantitation, molecular HLA typing utilizing polymerase chain reaction (PCR), SSP, SSO, SBT, NGS, agarose preparation and gel electrophoresis, interpretation of all HLA typing results and various HLA antibody screening methods and interpretation.
• Work products and documents related to the identification of unusual HLA antibody and typing patterns; maintain leadership and support role to staff; perform final review analysis process and determine any discrepancies which need resolution; participate in the review and audit of laboratory records and SOPs.
• Work products and documents related to maintaining documents related to the verification and recoding of specimens; maintain documents related to quality assurance practices; provide a leadership role in taking the initiative to implement changes upon request.
• Work products and documents related to test/assay development, validation and implementation of new equipment and reagents; perform validation and recording of specimens in all appropriate software-based applications.
• Work products and documents related to troubleshooting in the areas of the laboratory software applications and instrumentation; monitor the quality assurance practices in all aspects of laboratory work; coordinate the teaching process of laboratory staff regarding new procedures and techniques.

Basic Qualifications:

• Master’s Degree in Genetics, Microbiology, or similar field of study
• American Board of Histocompatibility and Immunogenetics certification eligible
• Experience with MS Office Suite

Preferred Qualifications:

• Ability to communicate effectively, orally and in writing, with non-technical and technical staff
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.

This position is contingent upon contract award.