Posted to MedZilla on 1/17/2020


United States, Scientist I, Analytical Development, Immunoassay SC_AS_13640-MZ


ProClinical is recruiting for the open, contracted position of Scientist I – Analytical Development, Immunoassay for our client, a clinical-stage vaccine company based in Gathersburg, MD. The ideal candidate for Scientist I will join their Analytical Development Department in Gaithersburg, MD. The qualified individual should have extensive experience with ELISA-based immunoassays, and the position requires initiation and involvement in the development and qualification/validation of quantitative immunoassays for vaccine products and process-related impurities (host cell proteins). The ideal candidate will make detailed observations, analyze data, interpret results, write qualification/validation reports and SOPs, and exercise appropriate technical judgment in the design, execution, and interpretation of experiments.  The candidate will receive general instructions from a supervisor and will work independently, as well as collaborate with other team members and other groups.


  • Develop immunoassays (ELISA) and label-free binding assays (SPR) for analysis and biological characterization of virus-like particle and protein nanoparticle vaccine products and process-related impurities (host cell proteins)
  • Responsible for preparation and characterization of host cell protein (HCP) standards and specific antibodies
  • Responsible for determination of process-related impurities.
  • Perform characterization studies to understand potential impact of impurities on safety and immunogenicity.
  • Apply new cutting-edge technologies for in-process testing and product biological characterization. Experience with Surface Plasmon Resonance (SPR) is highly desired
  • Support Discovery testing needs for the projects in the pipeline
  • Perform method qualification/validation, and method transfer to other departments (e.g. QC)
  • Thoroughly analyze results and methods, solve analytical problems, and troubleshoot assays
  • Maintain effective communication with process development, formulation, QC, discovery, and clinical groups
  • Write, review, and edit SOPs and qualification/validation reports
  • Prepare technical reports and scientific journal publications and presentations. Provide selected sections for CMC regulatory filing
  • Present scientific findings at internal meetings and external conferences
  • Preparation and characterization of critical reagents and data trending

Skills And Requirements

  • Master’s degree with 5 years’ experience in related field, or Ph.D. in biological science with minimum of 2 years’ experience in related field.
  • Thorough understanding of immunoassay, enzyme assays, and label-free binding techniques in protein analysis.
  • Ability to critically analyze data using statistical tools.
  • Proficient in Microsoft Excel and/or other statistical tools to critically analyze data.
  • Excellent record keeping abilities to adequately record, analyze, and document analytical data generated in support of regulatory requirements.
  • Ability to work effectively with cross-functional groups.
  • Ability to prepare technical reports and presentations.
  • Understanding of GMP requirements and other FDA regulatory requirements associated with analytical testing of vaccine products.

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