GMP Manufacturing Associate II (NCI Vector Production Facility)

GMP Manufacturing Associate II (NCI Vector Production Facility)

Job ID: req3163
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: NIH
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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION         

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 Monitoring Research Program Directorate (CMRPD) provides support of innovative T-cell therapies and vector production for cancer treatment facilities within the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch (SB), Vector Production Facility.

KEY ROLES/RESPONSIBILITIES

• Works as part of a small team to execute GMP runs to produce clinical grade vector products in close collaboration with Process Development and Quality Assurance and Quality Control units
• Assists in the development of standard operating procedures, batch records, deviations, and change controls
• Reviews manufacturing records and test data
• Identifies potential bottlenecks and works with 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
• Maintains reagent inventories, order supplies, cleans laboratory areas, hoods, incubators, and group equipment, and assures equipment and facility functionality and preventative maintenance/qualification/certification for use
• Manages facility cleaning programs, change controls, and ensures contractors are following SOPs
• Manages/schedules manufacturing change overs in the Vector Production Facility
• Manages the Environmental Monitoring (EM) Program and the EM sample collection for the facility
• Tracks EM samples (testing, results, actions)
• Performs required data analysis, compiles data, and prepares results for review
• 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 educational requirements, a minimum of two (2) years of progressively responsible job-related experience
• Cell culture processing experience
• Excellent aseptic/sterile techniques
• 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
• Ability to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience with handling and propagation of immortalized cell lines e.g., HEK293s
• 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)
• Demonstrated ability to work both independently and as a member of a team
• Demonstrated ability to train and supervise others

JOB HARZARDS 

• 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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