Leidos Biomedical Research, Inc. (LBRI), a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research (FNLCR). FNLCR is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). It is the only FFRDC dedicated to biomedical research. Through its status as an FFRDC, FNLCR provides NCI and others with a unique national resource to accelerate the development and delivery of effective preventive, diagnostic, and therapeutic products for cancer and AIDS.
The breadth of FNLCR’s activities spans the research and development spectrum, including investigator-initiated, hypothesis-driven research into cancer and AIDS; advanced technology programs focused on genetics and genomics, proteins and proteomics, imaging, nanotechnology, bioinformatics, and laboratory animal sciences; clinical operations in support of NCI and National Institute of Allergy and Infectious Diseases (NIAID)-sponsored clinical trials, as well as NCI drug discovery and development efforts; and management and operations of biopharmaceutical development and manufacturing programs under current Good Manufacturing Practice conditions for NCI and NIAID. Administrative, procurement, financial, safety, and facilities support is provided to these R&D activities through state-of-the-art business processes. LBRI has approximately 1,900 employees and manages an annual operating budget of approximately $450M.
For more information about Leidos Biomedical Research Inc., please visit our webpage at http://www.leidosbiomed.com/
The Molecular Characterization Laboratory (MoCha) is part of Leidos Biomedical Research’s Clinical Research Directorate (CRD) at the Frederick National Laboratory for Cancer Research. The MoCha Laboratory is responsible for providing high-level research in support of the NCI-Cancer Diagnostics Program (CDP) within the Division of Cancer Treatment and Diagnosis (DCTD). MoCha is charged with the development and application of genomic assays for use in medical research and diagnostics for DCTD-sponsored national extramural clinical trials.
This position is an integral part of a multi-disciplinary team effort leading the implementation of next-generation sequencing in nation-wide clinical trials seeking to identify prospective treatments for cancer patients. The MoCha laboratory is comprised on two units – the CLIA Laboratory, which includes the sequencing and histology laboratories, and Research & Development. This position will primarily support the CLIA laboratories.
The Quality Assurance Manager I (QAM1) supports the Quality Management Program oversight for the laboratory’s regulated work. Specific duties include: 1) conducting quality reviews/audits (study-specific, process-based, and facility based) within the CLIA laboratories, 2) assisting in the review and updating of standard operating procedures and laboratory policies, 3) participating in the drafting, review, and finalization of assay validation plans/reports as well as other quality-related documents, 4) reviewing operational and study-specific records generated by the CLIA laboratories, 5) reviewing and preparing clinical reports for release, 6) assisting with the management of the CLIA Laboratory’s integrated quality systems, including change control/deviation reporting, training, document control, archiving, 7) representing the QA group at team meetings and during interactions with clients/subcontractors, including project network laboratories, 8) provides limited assistance with the quality efforts of Research & Development activities, and 9) traveling up to 10% of the time.
This position is located in Frederick, MD.
Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research or relevant scientific discipline, or a minimum of four (4) years relevant experience in lieu of a degree
Foreign degrees must be evaluated for US equivalency
Four (4) years of progressively responsible quality related experience including one (1) year of experience in a leadership capacity (may be pharmaceutical, clinical, etc.)
Familiar with CLIA and/or College of American Pathologists (CAP) accreditation
Knowledge of QA concepts and practices, and in the management and oversight of quality systems (e.g., change control, deviation reporting, training, document control, review and inspections)
Knowledge of quality control applications, preferably in molecular analysis and next-generation sequencing
Ability to independently conduct audits and quality reviews
Ability to communicate effectively, both verbally and in writing, with non-technical and technical staff at various levels of the organization
Must be detail oriented with strong organizational, analytical, and problem-solving skills and the ability to multi-task
Ability to function independently and collaboratively within a team setting
Familiarity with interactive databases, auditing techniques, metrics development and analysis, risk assessment
Ability to travel approximately 10%
Working knowledge of Word, Access, Excel, PowerPoint
Knowledge of Food and Drug Administration (FDA) Good Practice regulations (GxP), including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and/or Good Manufacturing practices (GMP)
Direct experience in archiving bio-specimens and related records