Position Summary:

 Performs and conducts independently novel non-cell and cell based immunoassays for complex scientific projects.

 Essential functions of the job include but are not limited to:

Performs assay development, qualification and validations as needed for all immunogenicity assays for therapeutic biologicals and gene therapy drug products

  • Conducts bioanalytical and immune assays including, but not limited to, ELISA, ELISPOT, MSD, ligand-binding assays, and PK assays to support cell-based therapeutics
  • Separate, isolate and cryopreserve primary cells peripheral blood mononuclear cells (PBMCs)
  • Completes all paperwork thoroughly and accurately for QA/QC and GxP purposes using Good Documentation Practices and updates computer-tracking systems, as required
  • Organizes data prior to submission
  • Ensures lab maintenance activities and equipment calibration are performed according to schedule
  • Ensures lab maintenance activities and maintains a clean and safe lab environment


Minimum Required:

  • Bachelor’s degree or equivalent combination of education and experience
  • 2-4 years of relevant laboratory experience

Other Required:

  • Experienced in using data analysis software like MS Excel, Graph Pad Prism and other statistical analysis software
  • Ability to interact and function in a highly productive work environment
  • Ability to work independently
  • Good attention to detail and documentation of data
  • Ability to lift and carry between 1-15 lbs.; Ability to lift up to 50 lbs. overhead with assistance; frequently required to sit, grasp, and use right/left finger dexterity; May be exposed to a cold freezer environment (Freezer temperatures range between -20ºC -196ºC)
  • Must be able to read, write, speak fluently and comprehend the English language
  • Availability to work during off-peak hours when business demands dictate. This may include occasional overtime, weekends and evening shifts


  • Prior experience in a GLP/GCLP environment
  • Experience in Cell Biology and Immunology
  • Experienced in tissue culture techniques with maintenance of cell lines in culture
  • Experience with LIMS

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