Rockville, Maryland

Join the HJF Team!

HJF is seeking a Laboratory Manager to support the Diagnostics and Countermeasures Branch's (DCB) Specimen Processing Laboratory and Biorepository (SPL/BioR) in Rockville, MD. Will oversee the daily operations and overall management of the Diagnostics and Countermeasures Branch's Specimen Processing Laboratory and Biorepository (SPL/BioR) for pre-analytical processing, storage and distribution of clinical specimens used in diagnostic and clinical evaluation of vaccine products and for other research protocol initiatives run by the Military HIV Research Program (MHRP), Emerging Infectious Diseases Branch (EIDB), and the Infectious Disease Clinical Research Program (IDCRP). will interact with researchers and external collaborators to coordinate projects that require specimen processing and Biorepository services. Ensures compliance with regulatory agency requirements to include, Good Clinical Laboratory Practices (GCLP), College of American Pathologists (CAP), and DOD Clinical Laboratory Improvement Program (CLIP) to maintain specimen integrity and efficient Laboratory and Repository Operations. HJF provides scientific, technical, and programmatic support services to DCB.

NOTE: As per Executive Order 14042, all HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.

Responsibilities:
  1. Manages daily operations of BioRepository and all specimen-processing activities in support of clinical research studies.
  2. Oversees the BioRepository and Laboratory Supervisors management of hiring, training and supervision of SPL/ BioR personnel including work schedules and annual appraisals.
  3. Ensures compliance with regulatory agency requirements to include, Good Clinical Laboratory Practices (GCLP, College of American Pathologists (CAP), and DOD Clinical Laboratory Improvement Program (CLIP) as well as other Sponsor/Network requirements.
  4. Participates in clinical protocol development meetings, as necessary, and assists the MHRP, IDCRP and EIDB protocol teams, to project workload requirements to ensure the laboratory is adequately staffed and trained.
  5. Oversees and manages use of Laboratory Information Systems (Freezerworks, LDMS, Q-Pulse, REES, etc) for accurate and efficient tracking of specimens and associated information, and migration data of transferred collections; upgrades systems as required.
  6. Sets goals and daily objectives for SPL personnel. Participates in hiring; trains and supervises SPL/BioRepository personnel; responsible for work schedules and annual performance appraisals.
  7. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Required Knowledge, Skills and Abilities:
  1. Performs specimen processing, as needed, and during high volume workloads.
  2. Assists Laboratory Director of the SPL/Biorepository in the development of specific study/protocol analytical plans, SOPs, estimated costs/budgets, and projected workload requirements for new projects. Assists Laboratory Director in establishing and maintaining laboratory quality/performance metrics for accuracy and efficiency within the SPL/BioRepository Operations; maintains BioRepository metrics including, but not limited to, specimen processing workloads by protocol, sample inventory, sample quality/integrity, overall workload metrics, shipments, and archival storage capacity.
  3. Assists Laboratory Director in preparation of annual report, annual SPL/Repository budget planning, monitoring quarterly budgets to alert DCB's Chief of Operations of any unexpected changes requiring budget adjustment.
  4. Coordinates with SPL/Biorepository clients, researchers, clinical sites and the Data Coordinating Centers to ensure adherence to protocol specific requirements; provides support and guidance for specimen handling, maintenance of specimen chain of custody, efficient, timely specimen processing, archival storage and/or distribution according to approved SOPs, protocol/study requirements, Informed Consent, and MTAs, CRADAs.
  5. Assists the Laboratory Director in evaluating operations to ensure efficient use of resources, appropriate staff resource management, new equipment acquisition, validation, and replacement schedules, rigorous backup systems, and recommendations for overall continued quality improvements.
  6. Ensures compliance with state and federal shipping regulations including renewal of appropriate IATA certifications and training of staff.
  7. Coordinates and approves the initiation and processing of purchase orders, supply sources, work orders and maintenance requests.

Minimum Education: Bachelor's degree required. Master's degree preferred.

Minimum Experience/ Training Requirements: A minimum of 9-10 years of experience required.

Physical Capabilities: Requires lifting materials up to 20lbs. Includes a variety of physical conditions, such as proximity to moving mechanical parts, electrical current, or exposure to chemicals.

Supervisory Responsibilities: Direct authority to make decisions on the following: employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and directs work activities.

Work Environment: This position takes place in a laboratory setting.

Work Arrangement: 100% on-site required.

Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC).

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, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.

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

Rockville, Maryland

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is a global organization dedicated to advancing military medical research. 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.

The not-for-profit Foundation is authorized by Congress to support research at the Uniformed Services University of the Health Sciences (USU) and throughout military medicine. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. The Foundation’s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and to accomplish their research goals effectively and efficiently.

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