Process Development Associate
Amgen Inc
Process Development Associate Scientist role supporting biopharmaceutical manufacturing at Amgen. The position involves sample preparation, analytical testing, and method development using biophysical techniques to characterize proteins and support product development and regulatory submissions.
Responsibilities
- Perform sample preparation, analytical testing, and method development using spectroscopic and biophysical techniques
- Characterize higher-order structure and aggregation attributes of biologics for product comparability studies
- Analyze complex data, interpret results, troubleshoot technical issues, and develop acceptance criteria
- Generate technical reports, presentations, and documentation supporting process development and regulatory submissions
- Collaborate with cross-functional scientific teams on product characterization and technology development
Requirements
- Bachelor's degree in chemistry, biochemistry, biotechnology, physics, or related field
- Hands-on experience with biophysical characterization techniques including IR, CD, UV-visible spectroscopy, and DSC
- Experience with HPLC systems for protein separation and characterization
- Demonstrated ability to develop, qualify, and validate analytical methods
- Strong laboratory skills including experimental design, data analysis, and technical record-keeping
- Ability to collaborate across multidisciplinary teams in a fast-paced environment
- Technical communication skills for reports, presentations, and regulatory documentation
Vacancy posted 5 days ago
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