Process Development Associate - Biological and Structural Characterization
Amgen Inc
Process Development Associate supporting biological and structural characterization of therapeutic proteins at Amgen. This operations role involves developing and implementing analytical methods for product testing, stability studies, and regulatory submissions within the manufacturing function.
Responsibilities
- Implement analytical potency methods for release testing, stability testing, and product characterization
- Prepare technical reports for investigations, characterization studies, and regulatory submissions
- Generate and analyze analytical data supporting product development and regulatory filing
- Contribute to analytical development teams with updates, documentation, and data interpretation
- Support method development, qualification, and technology transfer projects
Requirements
- Bachelor's degree, OR Associate's degree with 2 years operations experience, OR high school diploma with 4 years operations experience
- Expertise in cell culture and cell biology techniques for quantitative protein activity determination
- Experience in cell-based bioassay development, qualification, and validation
- Knowledge of signal transduction, gene expression, receptor binding, and fluorescent probe technologies
- Strong documentation skills and attention to detail
- Effective communication and interpersonal abilities
- Experience with automated liquid handling systems preferred
Vacancy posted 9 days ago
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