QC Analyst I

Within Leidos Biomedical Research Inc., the Clinical Research Directorate (CRD), various clinical support teams provide 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), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRD'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, CRD 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. CRD'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.

The Clinical Research Directorate (CRD) provides analytical experience to work on innovative T-cell therapy for cancer treatment, and responsible for development and execution of analytical assays for generation lot release assays and product CoAs in support of the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Surgery Branch (SB).

This position description does not represent a current opening but may be used to identify candidates with skills and experience for positions within Leidos Biomedical Research that frequently become available. Candidates who express an interest may be considered for future positions at Leidos Biomedical Research.

KEY ROLES/RESPONSIBILITIES

• Perform QC testing of materials manufactured for first-in-human immunotherapy clinical trials
• Perform cell culture of human primary cells, ELISA, FACS, PCR and qPCR assays as required for lot release
• Perform required data analysis, compile data and prepare results for review
• Participate in internal assessments and audits
• Plan own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities
• Interpret test results, compare to established specifications and control limits and makes recommendations on appropriateness of data for release
• Train new employees as required on techniques and SOPs
• Be responsible for data documentation and technical writing
• Be responsible for daily maintenance laboratory tasks
• This position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
• No experience required with a Bachelor's degree
• Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
• Ability to follow SOPs and comply with cGMP regulations
• Develop analytical methods and generate SOPs
• Perform a variety of analyses including computer-based instrumental analytical methods
• Good technical writing skills
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• General knowledge of Biosafety Level 2 (BL2)
• Analytical equipment qualification
• Demonstrated ability to interface with Manufacturing, Quality Assurance, Materials Management

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