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
Process Development Associate in thousand oaks at Unknown Company
This position is listed as full time and onsite.