OverviewChenega Services and Federal Solutions, LLC, is seeking a
Technical Manager to provide technical leadership, laboratory management, assay validation support, and quality oversight for the Diagnostics Systems Division. The position coordinates laboratory operations supporting Research Use Only (RUO), GLP, GLP-like, FDA Animal Rule, CLIP, and COLA-regulated testing activities. The incumbent oversees high-volume RT-PCR testing and extraction activities, supports diagnostic assay transition and validation studies, manages laboratory personnel, maintains quality systems and SOPs, supports environmental testing programs, serves as a technical lead and trainer, and ensures compliance with applicable regulatory and quality requirements.
Responsibilities- Coordinate and oversee the activities of assigned technical personnel supporting RUO, GLP, and GLP-like laboratory operations.
- Manage laboratory workloads supporting approximately 10,000-20,000 RT-PCR assays and 1,500-4,000 nucleic acid extractions annually.
- Maintain safe laboratory operations and ensure compliance with occupational health and safety requirements.
- Design, support, review, and provide technical feedback for assay validation and transition studies supporting movement of diagnostic assays from research use toward assay production or FDA pre-EUA requirements.
- Support assay validation studies including inclusivity, exclusivity, limit of detection, limit of quantitation, and statistical evaluation activities.
- Prepare and submit monthly GLP Data Reports.
- Prepare and submit quarterly GLP Workload Reports.
- Ensure laboratory testing and documentation comply with study protocols and regulatory requirements, including GLP, FDA Animal Rule, CLIP, and COLA standards.
- Procure critical reagents, quality control materials, and laboratory supplies.
- Qualify and maintain reagent lots and quality control materials supporting diagnostic testing activities.
- Serve as technical lead for laboratory training and competency assessments.
- Train, evaluate, and qualify laboratory personnel on diagnostic assay performance and laboratory equipment operation.
- Implement, manage, maintain, and revise PCR Core Laboratory SOPs in coordination with the Division Quality Manager.
- Review study data and approve results for release in accordance with quality assurance and quality control requirements.
- Operate laboratory facilities, instrumentation, and associated infrastructure.
- Schedule and coordinate preventative maintenance, repairs, and service activities for laboratory equipment.
- Perform laboratory experiments, data collection, and scientific analyses supporting the Special Pathogens Laboratory and Diagnostic Systems Division.
- Conduct environmental sample testing under ISO/IEC 17025 requirements.
- Maintain required qualifications and certifications supporting ISO/IEC 17025 testing activities.
- Maintain training and qualification requirements for the DSD GLP Validation Study Director role.
- Support oversight of GLP validation studies conducted within the Diagnostic Systems Division.
- Present technical findings at local and external scientific meetings.
- Support diagnostic missions, training events, and scientific presentation activities through CONUS and OCONUS travel.
- Other duties as assigned
Qualifications- Bachelor's degree in Molecular Biology, Microbiology, Biomedical Science, Biological Sciences, Biotechnology, Clinical Laboratory Science, or a related scientific discipline.
- Typically requires experience consistent with a Project Manager 1 labor category supporting technical project coordination and laboratory operations.
- Experience supporting molecular diagnostics, PCR-based testing, biological assay validation, or laboratory operations.
- Experience coordinating technical staff, laboratory workloads, or project activities.
- Experience supporting GLP-regulated laboratory environments.
- Experience reviewing and maintaining laboratory quality records and regulatory documentation.
- Experience supporting assay validation studies and quality control programs.
- Experience developing, implementing, or maintaining laboratory SOPs.
- Experience operating laboratory instrumentation and supporting equipment maintenance programs.
- Experience preparing technical reports, laboratory metrics, workload reports, or project documentation.
- Ability to work independently within regulated laboratory environments.
- Ability to obtain and maintain BPRP enrollment.
- Successfully pass background and drug screening
Preferred Qualifications:
- Experience supporting FDA Animal Rule, CLIP, COLA, ISO/IEC 17025, or similar regulated laboratory environments.
- Experience performing RT-PCR, molecular diagnostic testing, and nucleic acid extraction procedures.
- Experience supporting assay validation, verification, or transition-to-production activities.
- Experience functioning as a Study Director or supporting GLP study oversight activities.
- Experience supervising laboratory staff, technical personnel, or training programs.
- Experience maintaining laboratory quality management systems and quality control programs.
- Experience supporting high-volume diagnostic testing operations.
- Experience presenting technical findings at scientific meetings or professional conferences.
- Experience supporting diagnostic response missions or biodefense programs.
Knowledge, Skills and Abilities:
- Knowledge of molecular biology, diagnostic testing, RT-PCR methodologies, and nucleic acid extraction procedures.
- Knowledge of laboratory quality systems, GLP requirements, FDA Animal Rule requirements, CLIP standards, COLA requirements, and ISO/IEC 17025 standards.
- Knowledge of assay validation methodologies including inclusivity, exclusivity, limits of detection, and limits of quantitation studies.
- Knowledge of laboratory operations, reagent qualification, quality control programs, and study documentation requirements.
- Knowledge of laboratory equipment maintenance, calibration, and operational readiness practices.
- Ability to coordinate technical personnel, laboratory workloads, and project activities.
- Ability to review scientific data and ensure compliance with quality assurance and quality control requirements.
- Ability to prepare technical reports, workload reports, SOPs, study documentation, and scientific summaries.
- Ability to train, mentor, and evaluate laboratory personnel.
- Ability to manage multiple priorities while maintaining compliance with regulatory and quality standards.
- Ability to communicate effectively with leadership, investigators, laboratory personnel, and quality management staff.
- Strong analytical, organizational, technical, documentation, and problem-solving skills.
- Ability to work independently and collaboratively within multidisciplinary laboratory environments.
