Cell Therapy Quality Control Scientist

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale.

KEY ROLES/RESPONSIBILITIES

• The Cell Therapy Quality Control Scientist will pursue the development and validation of quality control testing in early phase immunotherapy clinical trials, to include safety, identity, potency.
• This position is in Bethesda,

BASIC QUALIFICATIONS

• Possession of a Doctoral degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/scientific discipline Foreign degrees must be evaluated for U.S. equivalency
• In addition to education requirement, a minimum of five (5) years of progressively responsible job-related experience. This includes working in a laboratory developing lentiviral and/or retroviral vectors for gene therapy and hands on experience with development/manufacturing of cellular therapies for human use
• Experience in cellular therapy manufacture or vector production
• Must be detail-oriented and possess strong organizational, analytical and problem-solving skills with the ability to prioritize multiple tasks/projects of highly complex scope
• Ability to perform job requirements independently and in team environments and must have ability to interface with all levels of management making decisions regarding complex issues
• Ability to develop and maintain manufacturing operations under cGMP compliance
• Possess knowledge of production-related principles of biopharmaceutical development and production processes
• Working knowledge of cGMPs as they relate to biopharmaceutical manufacturing
• Capable of ensuring quality control and fiscal planning
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Proficiency in Microsoft Office® inclusive of Word, Excel, Access and PowerPoint
• Principles of timelines within Microsoft® Project
• Familiarity with interactive databases quality assurance, quality systems, auditing, metrics analysis, cancer

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)