OverviewThe Assay-Development Lead Technician provides advanced laboratory and scientific support for assay development, molecular diagnostic testing, and biodefense research activities within the Diagnostic Systems Division. This position performs complex laboratory procedures in BSL-2, BSL-3, and BSL-4 environments to support assay development, sample testing, molecular diagnostics, microbiology, and diagnostic research programs. The incumbent collaborates with Principal Investigators and laboratory personnel to execute experimental designs, analyze scientific data, support regulatory and quality initiatives, develop technical documentation, conduct training activities, and contribute to scientific research, reporting, and publication efforts. The position serves as a technical leader, provides mentorship to junior personnel, and supports laboratory biosafety, compliance, and operational excellence initiatives.
Responsibilities- Perform laboratory work required to fulfill the experimental design for assay development and sample testing as determined in collaboration with the respective project PI in BSL-2, BSL-3 and BSL-4 laboratories.
- Maintain access to BSL-2, BSL-3, and BSL-4 laboratories. Conduct training of new laboratory members in BSL-2 and BSL-3 laboratories. Serve as containment suite supervisor or assistant suite supervisor of assigned area.
- Maintain a safe workplace; comply with occupational health and safety rules and regulations.
- Shall conduct clinical, environmental, in vitro, and in vivo animal sample processing and testing in BSL-2, BSL-3, and BSL-4 laboratory conditions using various molecular biology techniques to include next-generation sequencing, quantitative and qualitative real-time PCR, and other methods.
- Perform microbiological assays and sample processing techniques (both basic and novel) in BSL-2, BSL-3 and BSL-4 laboratories to generate nucleic acid material for molecular diagnostic tests.
- CONUS/OCONUS travel may be required in support of the diagnostic mission, training, and/or presentation of scientific research. Travel locations may include remote, resource-limited locations.
- Perform testing and data analysis for molecular diagnostic assays from BSL-2, BSL-3, and BSL-4 samples and unknown diagnostic samples.
- Perform microbiological techniques to include clinical microbiology, blood culture, differential plating, and basic phenotypic characterization.
- Perform sample processing techniques to include: QIAgen EZ1, MagNA Pure, and manual column-based techniques as well as novel molecular enrichment protocols for next generation sequencing and real-time PCR.
- Perform manual, semi-automated and automated experiments and procedures in support of the GLP PCR and GLP PCR-like work, including PCR, immunoassays, sample preparation and DNA/RNA extraction and purifications as well as common molecular, immunological, and microbiology techniques in BSL-2 and BSL-3 environments.
- Present protocols and data generated at weekly meetings.
- Assist the PIs in preparation of standard operating procedures, technical reports, and manuscripts for publication.
- Perform experiments, data collection and analysis in support of the Special Pathogens Laboratory and other Diagnostic Systems Division labs.
- Conduct environmental sample testing under ISO/IEC 17025 conditions within the Special Pathogens Laboratory. Maintain certification to conduct testing under ISO/IEC 17025.
- The number of reports, data and SOPs required will vary per year depending on the number of funded projects available, but the typical workload is facilitating research on 2-5 projects per year. Shall contribute to Assay-Development Quarterly and Annual Reports for associative projects and protocols.
- Provide assistance with the FIBWA training program by conducting classroom instruction, facilitating hands-on practical exercises, and providing over-the-shoulder training for service members, civilians, and designated personnel as required. Estimated level of effort is 2-8 courses per year.
- Provide the TPOC Assay-Development data and SOPs for responsible projects NLT the last workday of each month as required.
- Other duties as assigned
Qualifications- Bachelor's degree in Biology, Microbiology, Molecular Biology, Biochemistry, Biotechnology, Life Sciences, or a related scientific discipline and seven (7) or more years of directly related laboratory experience; OR Master's degree in a related scientific discipline and three (3) or more years of directly related laboratory experience.
- Demonstrated experience performing laboratory procedures, scientific testing, research activities, and technical support functions within microbiology, virology, molecular biology, immunology, biochemistry, or related scientific disciplines.
- Experience independently executing complex laboratory procedures and scientific protocols.
- Experience performing data collection, analysis, interpretation, and technical documentation activities.
- Experience working within regulated laboratory environments and adhering to quality standards and established laboratory procedures.
- Experience developing or supporting SOPs, laboratory documentation, and technical reports.
- Experience training and mentoring laboratory personnel.
- Ability to maintain laboratory access requirements and complete all required biosafety training.
- Ability to obtain and maintain BPRP enrollment and all required laboratory credentials.
- Successfully pass background and drug screening
Preferred Qualifications:
- Experience working within BSL-3 and/or BSL-4 laboratory environments.
- Experience supporting biodefense, infectious disease, diagnostic, or Special Pathogens research programs.
- Hands-on experience with next-generation sequencing platforms and workflows.
- Experience with quantitative and qualitative real-time PCR testing methodologies.
- Experience performing microbiological testing, pathogen characterization, and molecular diagnostics.
- Experience using QIAgen EZ1, MagNA Pure, and other automated nucleic acid extraction systems.
- Experience supporting GLP-compliant laboratory programs.
- Experience conducting testing under ISO/IEC 17025 requirements.
- Experience serving in a laboratory lead, supervisory, or containment suite management role.
- Experience developing SOPs, technical reports, scientific publications, or research manuscripts.
- Experience delivering classroom instruction, laboratory training, and technical mentoring programs.
- Experience supporting military, federal, or DoD research organizations.
Knowledge, Skills and Abilities:
- Advanced knowledge of molecular biology, microbiology, diagnostic testing, and laboratory research methodologies.
- Knowledge of biosafety, biosecurity, occupational health, laboratory compliance requirements, and high-containment laboratory operations.
- Knowledge of next-generation sequencing, PCR, real-time PCR, immunoassays, nucleic acid extraction, and molecular diagnostic techniques.
- Knowledge of GLP principles, quality systems, laboratory accreditation standards, and ISO/IEC 17025 requirements.
- Knowledge of laboratory documentation practices, data integrity requirements, and scientific record management.
- Ability to independently plan, execute, troubleshoot, and analyze complex laboratory experiments and testing activities.
- Ability to evaluate scientific data and prepare technical reports, SOPs, research summaries, and project deliverables.
- Ability to lead technical efforts and provide mentorship and guidance to laboratory personnel.
- Ability to effectively train personnel through classroom instruction, practical exercises, and hands-on laboratory demonstrations.
- Ability to communicate complex scientific information to technical and non-technical audiences.
- Strong analytical, organizational, critical-thinking, and problem-solving abilities.
- Strong verbal and written communication skills.
- Ability to manage multiple projects simultaneously while meeting deadlines and maintaining quality standards.
- Ability to work independently and collaboratively within multidisciplinary scientific teams.
- Proficiency in scientific data management, documentation, reporting, and presentation of technical findings.
