Research Associate II, Internal Quality Control

Research Associate II, Internal Quality Control

Job ID: req3439
Employee Type: exempt full-time
Division: Applied & Development Research Program
Facility: Frederick: Ft Detrick
Location: PO Box B, Frederick, MD 21702 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

The Frederick National Laboratory for Cancer Research (FNLCR) is a Federally Funded Research and Development Center sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. With more than 2,000 employees, the FNLCR is responsible for pursuing translational and applied biomedical research that is unique from academia, the pharmaceutical industry, or other federal contractors. The selected candidate will join the Clinical Pharmacodynamic Biomarkers program (CPD program), located at the NCI-Frederick campus.

The CPD Program is responsible for identification of biomarkers of response to new targeted agents entering clinical trials in the Developmental Therapeutics Program of the National Cancer Institute (NCI). The scope of work includes assay design, development, validation, fitness for purpose testing, transfer, and support of assays to internal and external clinical laboratories, and clinical specimen analysis when required. The Internal Quality Control (IQC) laboratory within the CPP program is responsible for maintaining an inventory, quality control testing, and distributing a large number of critical reagents and control materials to support the conduct of validated clinical pharmacodynamic assays across several technology platforms within a network of internal and external laboratories.

KEY ROLES/RESPONSIBILITIES

• Perform incoming quality control testing and data analysis on critical reagents for validated clinical pharmacodynamic assays across several technology platforms (i.e., UV/Vis spectroscopy; SDS-PAGE; multiplex immunofluorescence assays for slide based clinical biopsy analyses and circulating tumor cells; ELISA, Western, and Luminex assays on extracted clinical biopsies and cellular extracts, etc.)
• Procure bulk quantities of antibodies and other critical reagents and conduct their analytical and performance testing according to reagent and clinical assay specifications
• Support the production and release of custom assay control and proficiency specimens
• Support the production and release of custom antibody conjugates
• Support a large inventory of assay critical reagents and associated electronic database
• Support the distribution of assay critical reagents to external and internal laboratories
• Collaborate with a diverse group of scientific staff responsible for initial development and validation of the clinical pharmacodynamic assays across several platforms and with core facilities providing testing support (histology, pathology, FFPE slide staining, whole slide image scanning, protein and antibody production, antibody conjugation, preclinical tissue generation, cell culture support, etc.)
• Master novel technologies and instrumentation in response to changes in project priorities or breakthrough technological innovations; hands-on instrumentation work is required for this position
• Maintain precise records
• Will be expected to multitask and able to handle numerous time sensitive tasks with a high level of accuracy

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. (Additional qualifying experience may be substituted for the required education)
  
• Foreign degrees will be evaluated for U.S. equivalency
  
• In addition to educational requirements, at least five (5) years experience for Bachelor’s degree candidates or at least three (3) years for Master’s degree candidates in a position related to assay development and/or assay support with some direct experience with assay reagent quality control and antibody analytical and performance characterizations
  
• Ability to obtain and maintain a security clearance
  

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Experience with one or more of the following techniques:  UV/Vis spectrophotometry, SDS-PAGE, cell culture, western blot, surface plasmon resonance, image cytometry, slide based multiplex immunofluorescence assay staining and analysis, sandwich ELISA, Luminex assays, immunoassay development, antibody conjugation, and protein characterization
  
• Ability to independently develop, modify methods and techniques
  
• Proficiency with Microsoft Office (Outlook, Excel, Word, and PowerPoint) software
  
• Quantitative laboratory work in biochemistry, biology, chemistry, and/or biotechnology

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

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

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