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Process Development Associate

Amgen Inc

Amgen seeks a Process Development Associate to support protein characterization and analytical method development for therapeutic biologics. The role involves chromatography studies, method qualification, and collaboration with cross-functional teams to advance manufacturing processes and support regulatory submissions.

Responsibilities

  • Develop and qualify analytical methods using HPLC, UPLC, and CE platforms
  • Perform chromatographic fractionation, peptide mapping, and LC-MS studies for product characterization
  • Document results in laboratory notebooks and method reports; transfer qualified methods to Quality Control
  • Conduct attribute identification, characterization, and accelerated stability studies
  • Support commercial process development and validation studies for marketing applications

Requirements

  • Master's degree in scientific field, or Bachelor's with 2 years experience
  • Experience with HPLC, UPLC, Capillary Electrophoresis, or mass spectrometry
  • Background in analytical method development and product characterization
  • Strong written and verbal communication skills
  • Ability to manage complex projects and work collaboratively in teams
  • Knowledge of GMP environments and regulatory requirements preferred
Vacancy posted 3 days ago
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