Life Sciences

Clinical Research Biologist

Bethesda, Maryland
Work Type: Full Time

Nextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Biologist to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Immunology Program (VIP).


  • Utilize established SOP’s to execute testing for clinical research trials.
  • Document testing parameters according to GCLP guidelines and analyze testing results.
  • Write and revise SOPs, evaluation and developments reports and analytical plans.
  • Develop testing activities and method protocols with senior staff.
  • Maintain cell lines and reagents necessary for assays.
  • Develop, optimize, and execute qualification and validation of methods.
  • Improve existing methodology and generation of novel research experiments while maintaining detailed documentation as per the SOPs.
  • Perform necessary QA/QC activities as per laboratory guidelines and the quality management plan.
  • Troubleshoot assays and adjust scientific methodology to correct problems or deficiencies in a research project or experiment.
  • Maintain accurate laboratory records to ensure proper retention of scientific data.
  • Maintain laboratory supplies inventories.
  • Attend staff meetings and regularly present experimental data.
  • Work collaboratively and independently as needed to adhere to project timelines.
  • Work with dry ice, freezers, and liquid nitrogen tanks to store clinical samples, and perform clinical testing in a BSL-2 environment while always wearing appropriate PPE.

Experience Required / Requirements

  • Bachelor’s degree or higher in a biology-related discipline.
  • Minimum of 2 years of experience in the pharmaceutical, vaccine, biologics, or similar industry is required.
  • Experience in aspects of clinical trial implementation and testing is preferred.
  • Familiarity with immunoassays, including pharmacokinetics, anti-drug antibody, and neutralization assays.
  • Experience in a GLP, GCLP, cGMP, laboratory.
  • Experience in a diverse set of clinical research techniques such as;
    • Immunoassay methodology – ELISA, ECLIA, ADA, SMC
    • Pseudovirus neutralization assay
    • Elispot Assays
    • Cell culture and other cell-based assays
  • Experience with automated systems such as liquid handlers and high-throughput robotic instruments is preferred.
  • Data analysis and use of analytical software.
  • Proficient in Microsoft work, PowerPoint, Prism and Excel.
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