Frederick National Laboratory for Cancer Research

Research Associate I, Clinical Pharmacodynamic/Internal QC

Frederick, MD, USA
Sep 05, 2020
Required Education
Bachelors Degree
Position Type
Full time
The Clinical Pharmacodynamic Program (CPP) 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, performing 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.

  • Perform incoming quality control testing on critical reagents for validated clinical pharmacodynamic assays across several technology platforms (i.e., multiplex immunofluorescence assays on slide based clinical biopsy analyses and circulating tumor cells; ELISA 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 a large inventory of assay critical reagents and associated electronic database
  • Support the distribution of assay critical reagents to external and internal laboratories

  • Possession of a Bachelor's degree from an accredited college or university (according to CHEA) in a field related to biomedical research. Foreign degrees will be evaluated for U.S. equivalency
  • In addition to the education requirement, a minimum of two years of related biomedical experience
  • Experience with one or more of the following techniques: Sandwich ELISA, Luminex assays, slide based multiplex immunofluorescence assay staining and analysis methods, immunoassay development, antibody conjugation, protein characterization, SDS-PAGE and/or Western blotting
  • Experience in inventory of qualified assay reagents, including procurement, handling, testing and distribution
  • Hands-on instrumentation experience
  • Ability to maintain precise records
  • Ability to obtain and maintain a security clearance

  • Experience 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
  • Experience in the following areas: antibody and protein analytical and performance quality control evaluations
  • Quantitative laboratory work in biochemistry, biology, chemistry, or biotechnology
  • Ability to master novel technologies and instrumentation in response to changes in project priorities or breakthrough technological innovations
  • Ability to collaborate with a diverse group of scientific staff responsible for initial development and validation of the clinical pharmacodynamic assays across several platforms and 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.)
  • Proficiency with Microsoft Office (Outlook, Excel, Word, and PowerPoint)
  • Ability to handle numerous time sensitive tasks with a high level of accuracy
  • Excellent verbal, written, organizational and communication skills

  • 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)