GMP Manufacturing Associate I - NIH

Job ID: req2559
Employee Type: nonexempt 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 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

• Assists with preparation of 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 monitor all assigned programs for compliance
• Assists with development and implementation of procedures/programs to ensure effective and efficient business and operational processes
• Helps to identify potential bottlenecks in the upcoming development process and works with all team members and senior management to resolve them
• Assists with coordination of logistics, including purchasing and shipping of miscellaneous equipment, lab and office supplies to ensure compliance with appropriate government regulations
• Maintains workflow and follows timelines to ensure production operations are on schedule and adequate raw materials and supplies are available
• Assists with technical audits of outsourced contractors in conjunction with Quality Assurance and or Quality Control
• Tracks EM samples (testing, results, actions)
• Follows PM schedule and reporting
• The 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 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
• No experience is required with a Bachelor's degree (relevant experience may be substituted for the degree)
• Possess knowledge of production-related principles of biopharmaceutical development and production processes
• Working knowledge of cGMPs as they relate to biopharmaceutical manufacturing
• Use of aseptic/sterile techniques
• Self-motivated and willing to accept/learn temporary responsibilities outside of the 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:

• Knowledge of handling and propagation of human primary cells, including T cells
• Strict adherence to SOPs and cGMP regulations, including excellent documentation skills
• Proficiency in Microsoft Office® inclusive of Word, Excel, Access, and PowerPoint
• Familiarity with interactive databases quality assurance, auditing, metrics analysis, cancer
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)

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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