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Process Development Senior Scientist

Amgen
Thousand Oaks, California, United States
On-site

About this role

About the Role In this vital role you will be responsible for analytical and biochemical characterization activities for pre-clinical biotherapeutic protein development, including assay development for biochemical characterization with emphasis on mass spectrometry and liquid chromatography. You will plan and execute work in support of pre-clinical candidate selection, process development, and lead molecule characterization. What You'll Do

  • Lead analytical and biochemical characterization activities for pre-clinical biotherapeutic protein development, including assay development with emphasis on mass spectrometry (MS) and liquid chromatography (LC).
  • Plan and execute studies in support of pre-clinical candidate selection, process development, and lead molecule characterization.
  • Develop analytical methods to assess biochemical characteristics of candidate drug products, including peptide mapping and intact protein LC-MS analysis.
  • Perform sample preparation (reduction/alkylation), enzymatic digestion, LC, MS, and peptide mapping workflows.
  • Characterize candidate molecules for protein primary structure and drug candidate chemical modifications/post-translational modifications; support quality attributes.
  • Utilize automation platforms and liquid handling systems; generate technical documents and presentations.
  • Provide scientific results to support regulatory submissions, patents, and publications; explore emerging MS-based technologies for characterization of therapeutic proteins. What We're Looking For
  • Experience in analytical and biochemical characterization of biotherapeutic proteins, with emphasis on MS-based methods (MS, LC-MS, peptide mapping, intact protein analysis).
  • Proficiency in sample preparation workflows, including reduction/alkylation, enzymatic digestion, LC, and MS.
  • Ability to plan, execute and interpret experiments for candidate molecule characterization and quality attributes.
  • Familiarity with automation platforms and liquid handling systems; strong documentation and presentation skills.
  • Experience contributing to regulatory submissions, patents, or publications is a plus. Nice to Have
  • Experience with peptide mapping and intact protein LC-MS analysis.
  • Knowledge of regulatory submissions and intellectual property documentation.
  • Familiarity with emerging technologies in MS-based protein characterization.

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