GMP Manufacturing Associate II (Cell Therapy)

Job ID: req2793
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. (operator of the Frederick National Laboratory for Cancer Research), the Clinical Research Directorate (CRD) provides clinical supervision of programs at the clinical end of the research spectrum. The quality assurance programs provide the required autonomy and transparency of Good Manufacturing Practice quality assurance operations. CRD also provides operational support for clinical research and supports clinical trials management, regulation, pharmacovigilance, and protocol development/protocol navigations. These support services include dedicated clinical research professionals who provide patient care to clinical trial participants at the National Institutes of Health (NIH) Clinical Center, and other research services that support the domestic and international clinical research initiatives of the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and several other institutes within NIH. CRD's support services are strategically aligned with its mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, protecting human subjects, and helping to advance scientific clinical research. CRD facilitates the conduct of NIH-sponsored clinical trials that investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, parasitic infections, heart, lung and blood disorders, and rare and neglected diseases. CRD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CRD's mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Research Directorate (CRD) provides support, 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

• Works as part of a small team executing GMP manufacturing runs to produce clinical grade vector products in close collaboration with Process Development, 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 all team members and senior management to resolve them
• Participates in investigations regarding out of specifications/trend results and 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)
• Supports Quality Control unit in an ancillary role by performing clinical testing of cell products manufactured for first-in-human immunotherapy clinical trials
• 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 (CHEA) 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 progressively responsible job-related experience or progressively responsible job-related experience in a cGMP environment, as designated by the Program requirements (may be pharmaceutical, clinical, etc.)
• 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 HAZARDS

• 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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