Process Development Sr Associate
$91.13k - $108.3kAmgen Inc
Amgen seeks a Process Development Senior Associate in Thousand Oaks, California to perform analytical method development and qualification studies using chromatography and mass spectrometry platforms. The role involves protein characterization, stability studies, and collaboration with cross-functional teams to support pharmaceutical process development and regulatory submissions.
Responsibilities
- Develop and qualify analytical methods using HPLC, UHPLC, and LC-MS for product characterization
- Conduct degradation pathway studies and accelerated stability testing to define therapeutic attributes
- Author method development reports and coordinate with Quality Control for method transfer
- Perform chromatographic fractionation and peptide mapping to support comparability studies
- Evaluate novel analytical technologies and collaborate on commercial process validation activities
Requirements
- Bachelor's degree in Chemistry, Chemical Biology, or related field
- 2 years analytical chemistry experience with protein molecules and degradation studies
- Proficiency with HPLC, UHPLC, LC-MS, and Capillary Electrophoresis platforms
- Experience with method qualification, transfer, and data analysis using Empower, Chromeleon, ChemStation software
- Troubleshooting capability across Waters, Agilent, and Maurice analytical instruments
- Knowledge of liquid chromatography principles and protein/peptide technical understanding
- GLP and GMP laboratory protocol implementation experience
Compensation: $91,125-$108,296 base
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