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
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