Manufacturing/Cell Therapy Specialist

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.

KEY ROLES/RESPONSIBILITIES

The Clinical Research Directorate (CRD) provides cell culture experience to work on innovative Vector Production and T-cell therapies for cancer treatment, and responsible for cell culture media preparation, vector production, and/or cell processing and cell expansion in the cGMP clinical manufacturing facility in support of the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Surgery Branch (SB).

• Performs testing of raw materials, intermediates, and final products by following analytical methods
• Maintains, calibrates and operates equipment and instruments supporting cell bioassays, Flow Cytometry, ELISA and PCR assay
• Tracks and tests products according to protocols
• Maintains lab in an optimal state
• Monitors and trends data, completes routine record review of test data and related documents for in-process testing, drug substance and drug product release
• Generates CoAs for product release
• Assists in the preparation of dossiers and data packages for interactions between Surgery Branch and Regulatory agencies
• Develops, revises, and reviews SOPs, qualification/validation protocols and reports
• Participates in investigations regarding out of specifications (OOS) results; address and manage deviations related to analytical procedures
• Provides updates at daily and weekly meetings
• Monitors the GMP systems currently in place to ensure compliance with documented policies
• Reviews proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
• Gathers metric information for use in continuous improvement of areas of responsibility
• May develop testing and analysis methods and procedures in accordance with established guidelines
• This position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a related field (Additional qualifying experience may be substituted for the required education)
• Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of two (2) years of progressively responsible job-related experience
• Cell culture processing experience
• Excellent aseptic/sterile techniques
• Experience with handling and propagation of human primary cells, including T cells
• Ability to strictly adhere to SOPs and cGMP regulations and accurately complete documentation associated with clinical manufacturing
• Proficiency in Microsoft Word, Excel and data analysis
• Ability to think critically and demonstrate strong troubleshooting and problem-solving skills
• Must be self-motivated and willing to accept temporary responsibilities outside of initial job description
• Excellent interpersonal, verbal and written communication skills
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Vector production and/or cell therapy products experience
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)

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