QC Analyst I - NIH/ NCI

QC Analyst I - NIH/ NCI

Job ID: req3711
Employee Type: nonexempt full-time
Division: Clinical Research Program
Facility: NIH
Location: 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 analytical experience to work on innovative T-cell therapy for cancer treatment, and responsible for development and execution of analytical assays for generation lot release assays and product CoAs in support of the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Surgery Branch (SB).

KEY ROLES/RESPONSIBILITIES

• Performs Quality Control (QC) testing of materials, intermediates, and final products manufactured for first-in-human immunotherapy clinical trials
• Performs cell culture of human primary cells, ELISA, FACS, PCR and qPCR assays as required for lot release
• Identifies potential bottlenecks and works with team members and senior management to resolve them
• Performs required data analysis, compiles data, and prepares results for review
• Interprets test results, compares to established specifications and control limits and makes recommendations on appropriateness of data for release
• Provides updates at daily and weekly meetings
• Assists in developing testing and analysis methods and procedures in accordance with established guidelines
• Coordinates maintenance and calibration of equipment and instruments used in testing of clinical products
• Monitors the GMP systems currently in place to ensure compliance with documented policies
• Assists with investigations regarding out of specifications (OOS) results; addresses and manages deviations related to analytical procedures
• Works collaboratively to develop, revise, and review SOPs, qualification/validation protocols and reports
• Participates in internal assessments and audits
• Plans own activities on a weekly basis in accordance with established schedules and in accordance with group objectives and priorities
• Trains new employees as required on techniques and SOPs
• Provides support with data documentation, technical writing, and document organization
• Performs daily maintenance and laboratory tasks
• This position is located in Bethesda, Maryland

BASIC QUALIFICATIONS

• Possession of a bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education)
• Foreign degrees must be evaluated for U.S. equivalence
• Good technical writing skills
• Ability to interface with stakeholders (ex. Manufacturing, Quality Assurance, Materials Management)
• Adherence to SOPs and compliance with cGMP regulations
• Must be able to obtain and maintain a clearance

PREFERRED QUALIFICATIONS

• General knowledge of Biosafety Level 2 (BL2)
• Aseptic technique
• Cell culture experience
• Working knowledge of current Good Manufacturing Practices (cGMP) and scientific principles
• Perform a variety of analyses including computer-based instrumental analytical methods

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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