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Process Development Senior Associate

Amgen Inc

Senior Associate in the Pivotal Drug Product Technologies group supporting late-stage biologics commercialization. Design and execute formulation and process development studies, perform analytical testing, build data solutions, and contribute to lifecycle management of drug products.

Responsibilities

  • Plan and design formulation and process development studies applying engineering and scientific principles
  • Execute and document laboratory studies including ultrafiltration, filtration, freeze-thaw, and stability testing
  • Evaluate product and process performance through analytical testing methods
  • Build data solutions using Spotfire, Smartsheet, and statistical analysis software to analyze datasets
  • Author and review technical protocols and reports; present findings to cross-functional teams

Requirements

  • Master's degree, or Bachelor's with 2+ years scientific experience, or Associate's with 4+ years, or high school diploma with 6+ years
  • Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, or Pharmaceutics preferred
  • 1+ years pharmaceutical or biotechnology experience including process characterization and formulation development
  • Knowledge of drug product unit operations and analytical techniques (SEC, CEX, HIAC, MFI)
  • Proficiency in statistical software (SAS, JMP, or Minitab)
  • Experience with programming languages and data visualization tools
  • Strong attention to detail, communication skills, and critical thinking
Vacancy posted 15 days ago
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