Cell Therapy / Quality Control Analyst III

Within the Leidos Biomedical Research Inc.'s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) 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 Institute of 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, CMRP'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. CMRP's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health 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, CMRP services include comprehensive clinical trials, 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. CMRP'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 Monitoring Research Program (CMRP) 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).

KEY ROLES/RESPONSIBILITIES

Quality Control Analyst III

• Collaborates on the development of templates and processes to enhance the performance of the program
• Provides organizational and document support including preparation of documents (spreadsheets, web pages, written narrative, meeting minutes) and timely communication with committee and working group members through email contact and websites
• Establishes, implements and maintains standardized processes and assess performance to make recommendations for improvement
• Prepares technical reports, abstracts, presentations and program correspondence concerning assigned projects through research and analysis of information relevant to government policy, regulations and other relevant data
• Monitors all assigned programs for compliance
• Facilitates communication through all levels of staff by functioning as a liaison between internal departments, senior management, and the customer
• Attends weekly meetings to discuss upcoming events, tasks, special projects and implementation plans
• Develops and implements procedures/programs to ensure effective and efficient business and operational processes
• Identifies potential bottlenecks in the upcoming development process and works with all team members and senior management to resolve them
• Analyzes and tracks initiatives and contracts
• Coordinates and reviews daily operations and logistics, including purchasing and shipping of miscellaneous equipment, lab and office supplies to ensure compliance with appropriate government regulations
• Aids in measuring, monitoring, problem solving, and reporting of research, operational and business issues
• Reviews operational requirements for development of or changes to staffing
• Performs all tasks associated with the manufacture of clinical product (vector or cell)
• Cross-trains on SOPs and procedures required to support both vector and cell production
• Follows batch records and SOPs
• Executes GMP runs in close collaboration with Process Development, Quality Assurance, and Quality Control groups
• Assists in the development of SOPs, batch records, deviations and change controls
• Troubleshoots processing and equipment issues
• Participates in investigations regarding out of specifications/trend (OOS/OOT) results; addresses and manages deviations to manufacturing procedures
• This position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• 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 the educational requirements, a minimum of five (5) years related experience
• Knowledge of GMP, SOPs, and quality control processes
• Experience identifying, writing, evaluating, and closing laboratory (OOS) investigations
• Proficiency in MS Word, Excel, Power Point and other applications
• Strong written and verbal communication skills
• Ability to communicate and work independently with scientific/technical staff
• Familiarity with analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Analytical assay 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)