PCR Core Laboratory - Technical Manager

Job Description

Join the HJF Team!

HJF is seeking a PCR Core Laboratory - Technical Manager to 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 shall be performed in BSL-2, BSL-3 and BSL-4 environments.

This position will be in support of United States Army Medical Research Institute of Infectious Diseases (USAMRIID) Technical Research Support Services located at Fort Detrick in Frederick, MD. USAMRIID works closely with other U.S. Army Medical Research and Development Command (USAMRDC) organizations, Department of Defense (DoD), the Interagency (including Interagency Laboratories), and private companies to accomplish its mission of protecting the Warfighter from biological threats and being prepared to investigate disease outbreaks or threats to public health. This includes conducting Research, Development, Testing, & Evaluation (RDTE) of medical countermeasure against biological threats and the safety, quality assurance, project management, and core support required for these research activities.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

Responsibilities

• Contractor shall maintain a safe workplace; comply with occupational health and safety rules and regulations.
• Contractor shall 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.
• Contractor shall prepare and provide the TPOC a GLP Data Report NLT the last day of each month and a GLP Workload Report NLT the last day of each quarter.
• Contractor shall ensure all experiments are performed and documented IAW applicable regulations dictated by study protocol (i.e. GLP, FDA Animal Rule, CLIP, COLA).
• Contractor shall procure key reagents, quality control materials; ensure integrity of reagent and quality control materials. Workload is approximately 4 lots of reagent per assay, totally approximately 25 qualifications
• Contractor shall serve as technical lead training at least 5 personnel in the use of equipment and performance of assays. May include ad hoc training and competency evaluation of other personnel
• Contractor shall implement and maintain over 20 PCR Core Lab SOPs in coordination with Division Quality Manager.
• Contractor shall review all study data within 4 business days of completion and approve data for release to ensure correctness and compliance with quality control and quality assurance guidance.
• Contractor shall independently operate and schedule maintenance and repairs of laboratory facilities and equipment; ensure maintenance and repairs are performed IAW requirements resulting in no more than 5 days of downtime
• Contractor shall perform experiments, data collection and analysis in support of the Special Pathogens Laboratory and other Diagnostic Systems Division labs.
• Contractor shall conduct environmental sample testing under ISO/IEC 17025 conditions within the Special Pathogens Laboratory. Maintain certification to conduct testing under ISO/IEC 17025.
• Contractor shall maintain training and certification for the DSD GLP Validation Study Director role. The Study Director oversees GLP studies conducted in the Diagnostic Systems Division.
• Contractor shall present work at local or off site scientific meeting 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.
• BPRP enrollment is required and shall be held and maintained IAW the provisions in this contract and all applicable regulations.
  
  

Supervisory Responsibilities

Assigned Lead: May recommend the following: employee hiring, disciplinary action, and starting salaries; provide input on employee performance evaluations

Qualifications

Education and Experience

• Minimum of a Bachelor's degree with 7 years' experience OR Master’s Degree with 3 years' experience
  
  

Required Knowledge, Skills And Abilities

• Knowledge of extremely complex laboratory procedures.
• Ability to meet deadlines of projects.
• Good communication and analytical skills.
• US Citizenship and the ability to obtain and maintain a T3/Secret Clearance and BRPR, CPRP, and/or CSPRP, including background check and drug screening.
  
  

Physical Capabilities

• Maintain sufficient health to meet enrollment criteria and maintain eligibility in USAMRIID’s Biological Personnel Reliability Program (BPRP), Chemical Personnel Reliability Program (CPRP) and/or Controlled Substances Personnel Reliability Program (CSPRP).
• Current on routine adult immunizations or proof of active immunity against HBV, MMR, Influenza, COVID-19, Tdap. Employees working directly with patients or research participants must receive a negative TB test.
• Lifting: Requires lifting materials up to 10 lbs.
• Ability to stand or sit at a computer for prolonged periods.
  
  

Work Environment

• This position will take place primarily in a laboratory and/or clinical setting.
  
  

Compensation

• The annual salary range for this position is $64,200 - $109,200. Actual salary/hourly pay will be determined based on experience, education, etc.
  
  

Benefits

• HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.
  
  

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals With Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35©

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.