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Analytical Scientist

3 months ago

Gaithersburg, Maryland, United States Diati Staffing Full time

We are seeking an Associate Scientist to join our Analytical Development department group of energetic LC/MS scientists. The qualified individual should have demonstrated proficiency with development and application of HPLC and/or Size Separation based methods for phase-appropriate characterization of protein or vaccine products, including Ion Exchange Chromatography, Size-Exclusion Chromatography (SEC), residual assays via HPLC-UV or HPLC-FLD analysis. The candidate will support development and qualification of molecular separation assays, OOS investigations and troubleshooting, writing SOP, development report and technical report for testing vaccine products.

Responsibilities include but not limited to:

  • Develop HPLC related method for the separation and identity of related proteins and/or impurities in nanoparticle vaccine products.
  • Responsible for leading experimental designs to characterize Drug Substance and Drug Product materials for various batches generated at NVAX and/or CMO sites.
  • Follow SOP to test in-process samples using HPLC to support process development and stability studies of nanoparticle vaccines.
  • Responsible for drafting qualification and/or validation protocols for test methods to evaluate in-process samples.
  • Maintain effective communication within Analytical Development and cross-functional teams.

Minimum Requirements:

  • MS in analytical science, chemistry, biochemistry, or related field with 4+ years of industry experience in biopharmaceutical and/or vaccine development.
  • BS in analytical science, chemistry, biochemistry, or related field with 6+ years of industry experience in biopharmaceutical and/or vaccine development.
  • Ability to critically analyze data using statistical tools and to compile and review technical reports.
  • Good understanding of statistical tools and knowledge of DOE (Design of Experiments) and QbD (Quality by Design) principles is a plus.