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 3 days ago
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