Manufacturing/Cell Therapy Specialist II
Job ID: req1490
Employee Type: exempt full-time
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest.
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 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).
- Works as part of a small team to execute GMP runs in close collaboration with Process Development and Quality Assurance and Quality Control groups
- Assists in the development of standard operating procedures, batch records, deviations and change controls
- Reviews manufacturing records and test data
- Identifies potential bottlenecks in the upcoming development process and work with all team members and senior management to resolve them
- Participates in investigations regarding out of specifications/trend (OOS/OOT) results; addresses and manages deviations related to manufacturing procedures
- This position is located in Bethesda, Maryland
- 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 education requirement, a minimum of two (2) years job-related experience
- Cell culture processing experience
- Excellent aseptic/sterile techniques
- Must be able to obtain and maintain a security clearance
- Experience with handling and propagation of human primary cells, including T cells
- Strict adherence to SOPs and cGMP regulations, including excellent documentation skills
- Excellent skill in Microsoft word, Excel and data analysis
- Vector production and/or cell therapy products experience
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
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