Scientist II, Radiochemist

Scientist II, Radiochemist

Job ID: req3050
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Poolesville: NIHAC
Location: 16701 Elmer School Rd Bldg102, Dickerson, MD 20842 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 Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD’s ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD’s support services are aligned with the program’s mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical support to the NIAID Division of Clinical Research (DCR) supporting clinical research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics.

KEY ROLES/RESPONSIBILITIES

• Develops and maintains laboratory procedures (e.g., QC equipment calibration, analytical methods, etc.)
• Maintains the inventory of lab supplies, as needed, to support laboratory activities
• Prepares non-radioactive compounds for radiochemistry (e.g., antibody fragmentation, electrophoresis, cell culture, etc.)
• Receives radioactive material from outside vendor(s) and properly dispose of the radio-waste
• Performs hands-on manufacturing of radiopharmaceuticals, using antibodies, small molecules, or biological compounds, following standard operating procedures and preparing the documents for the product batch records
• Performs quality control and stability testing of radiopharmaceuticals (e.g., HPLC, TLC, etc.)
• Performs in-vitro and ex-vivo experiments with radiotracers (e.g., cell binding assays, autoradiography, ELISA, etc.)
• Support and conduct ongoing and future radiochemical production activities for clinical trials and preclinical studies, including planning, preparation, execution of radiochemical processes, and quality control
• Performs all work in compliance with lab safety rules, radiation protection guidelines and regulations, including cooperation and communication with health physicists, authorized users, and radiation safety officers
• Assists in the interpretation of research data and work collaboratively to prepare abstracts and publications of study results
• Assists in the design and execution of research studies
• Provides scientific expertise and guidance in support of research needs and scientific perspective to inform, design, and interpret sub-studies
• Provides insight into the laboratory and research processes to facilitate the development of investigative products
• Collaborates in the establishment and management of research studies that inform Phase 0-III clinical research protocols
• Ability to work with nonhuman primate (healthy and SIV-infected) blood, urine, cells, and tissues.
• This position is primarily located at the NIH Animal Center in Dickerson, Maryland with occasional (20%) travel to the Fisher’s Lane, Rockville, Maryland location.

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a Doctoral degree (M.D. /Ph.D.) from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) appropriate to biomedical research
• Foreign degrees must be evaluated for U.S. equivalency
• In addition to educational requirements, a minimum of two (2) years of progressively responsible relevant experience in the clinical operational support of multi-center international and domestic clinical trials
• Experience in radiolabeling, purification, validation, and development of antibody-based nuclear imaging probes in clinical/pre-clinical settings is preferred
• Ability to obtain and maintain a security clearance

JOB HAZARDS

• This position is subject to working with, or have potential for exposure to, animal(s)
  and/or animal material(s)
• This position is subject to working with or have potential for exposure to infectious
  material, requiring medical clearance and immunizations
• This position is subject to atmospheric conditions that would require the usage of a
  respirator, requiring a medical clearance
• This position is subject to working with radioactive material and requires candidate to become
  an approved radiation worker

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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