Manufacturing/Cell Therapy Associate II

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.

The Clinical Monitoring Research Program Directorate (CMRPD) provides implementation and oversight of multiple NCI/CCR cell processing facilities within the National Cancer Institute's (NCI's), Center for Cancer Research (CCR), Surgery Branch Cell Production Facility.

KEY ROLES/RESPONSIBILITIES

• 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 and monitors all assigned programs for compliance
• Provides project management support with planning and development of project schedules and deliverables, tracking project milestones, managing timelines, preparing status reports, and monitoring progress ensuring adherence to deadlines
• Facilitates communication through all levels of staff by functioning as a liaison between internal departments, senior management, and the customer
• Serves as leader/mentor to administrative staff
• 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
• Coordinates the administrative, fiscal, contractual, and quality aspects of all projects
• Ensures that internal budgets, schedules, and performance requirements are met
• Monitors workflow and timelines to ensure production operations are on schedule and adequate raw materials and supplies are available
• Ensures all activities are in compliance with applicable federal regulations and guidelines and proper testing/validation activities have been scheduled and conducted
• Regularly interacts with senior or executive management both internally and externally, on matters concerning several functional areas such as operations, quality control, and quality assurance
• Participates in planning facility or operations modifications, upgrades, and renovations
• Performs technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control
• Assists in the evaluation and selection of staff, planning and coordination of training, assigning of tasks and scheduling workloads, and evaluating overall performance annually
• Manages the Environmental Monitoring Program and the environmental monitoring sample collection
• Schedules, tracks and collects Environmental Monitoring samples
• Manages the Materials Management Program
• Manages equipment and facility preventative maintenance
• Establishes/manages Preventative Monitoring contract, schedule, and reports
• Manages facility cleaning programs, change control, and ensures contractors are following SOPs
• Manages/schedules manufacturing change overs in the Cell Processing Facility
• Trains and supervises new employees and junior employees on existing protocols and SOPs
• Reviews routine records, test data, and patient binders
• Participates in process investigation and deviation
• The position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college/university in a field related to biomedical research/scientific discipline or four (4) years relevant experience in lieu of degree
• Foreign degrees must be evaluated for U.S. equivalency
• A minimum of two (2) years of job-related experience, as designated by the Program requirements (may be pharmaceutical, clinical, etc.)
• Possess knowledge of production-related principles of protocol generation and adherence, strict laboratory documentation, and good laboratory documentation, and good laboratory practices (GLPs)
• Working knowledge of cGMPs as they relate to biopharmaceutical manufacturing
• Experience with aseptic/sterile techniques
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Experience with handling and propagation of human primary cells, preferably T cells
• Experience in cellular therapy manufacturing
• Strict adherence to SOPs and cGMP regulations, including excellent documentation skills
• Proficiency in Microsoft Office® inclusive of Word, Excel, Access and PowerPoint
• Principles of timelines within Microsoft® Project
• Familiarity with interactive databases quality assurance, auditing, metrics analysis, cancer
• Cell therapy products experience
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
• Ability to communicate with technical and scientific staff

JOB HAZARDS

• Candidate will be working with or have the potential for exposure to infectious material(s) or Other Potentially Infectious Materials (OPIM), requiring medical clearance and immunization in accordance with protocol requirements

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

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