PCR Core Laboratory Technical Manager

PCR Core Laboratory Technical Manager

Work Location: Fort Detrick, MD

Eagle Health is seeking a PCR Core Laboratory Technical Manager to join our team in Fort Detrick, MD.

Core Duties:

• Coordinate and oversee activities of the 2 to 4 assigned technical support personnel performing Research Use Only (RUO), GLP, and GLP-like work; workload is typically between 10,000 and 20,000 RT-PCR assays and 1,500 to 4,000 extractions per year. Experiments will be performed in BSL-2, BSL-3 and BSL-4 environments
• Maintain a safe workplace; comply with occupational health and safety rules and regulations
• Design, assist, and provide feedback for studies and activities associated with transitioning diagnostic assays from research use to assay production or FDA pre-EUA approval, to include but not limited to, inclusivity, exclusivity, limits of detection, limits of quantitation studies, and basic statistical analysis; workload is 4 to 5 validations/transitions per year
• Prepare and provide the technical point of contact (TPOC) a GLP Data Report no later than (NLT) the last day of each month and a GLP Workload Report NLT the last day of each quarter
• Ensure all experiments are performed and documented in accordance with (IAW) applicable regulations dictated by study protocol (i.e., GLP, FDA Animal Rule, CLIP, COLA, etc.)
• Procure key reagents and quality control materials and ensure integrity of reagent and quality control materials; workload is approximately 4 lots of reagents per assay, total approximately 25 qualifications
• Serve as technical lead training at least five (5) personnel in the use of equipment and performance of assays; may include ad hoc training and competency evaluation of other personnel
• Implement and maintain over 20 PCR Core Lab standard operating procedures (SOPs) in coordination with Division Quality Manager
• Review all study data within four (4) business days of completion and approve data for release to ensure correctness and compliance with quality control and quality assurance guidance
• Independently operate and schedule maintenance and repairs of laboratory facilities and equipment and ensure maintenance and repairs are performed IAW requirements resulting in no more than five (5) days of downtime
• 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 and maintain certification to conduct testing under ISO/IEC 17025
• Maintain training and certification for the DSD GLP Validation Study Director role. The Study Director oversees GLP studies conducted in the Diagnostic Systems Division
• Present work at local or off-site scientific meetings 1-2 times per year
• 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
• Biological Personnel Reliability Program (BPRP) enrollment is required and will be held and maintained IAW the provisions in this contract and all applicable regulations