Sr Associate Scientist – Attribute Sciences
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Scientific leadership of analytical and biochemical characterization activities for biotherapeutic protein commercialization, including: assay development, planning and execution in support of process characterization, product characterization, regulatory filing, response to regulatory questions and process/analytical investigations. Specific activities will include characterizing process influence on protein primary structure in drug substance and drug product, as well as characterizing stability against degradation product formation during storage. Develop and apply characterization strategies to drug substance and drug product comparability studies, characterization of product degradation pathways, and reference standard characterization. In addition, there will be a focus on developing technologies to reduce cost of quality, including impureomics / proteomics technologies, implementation of mass spectrometry in QC, and multi-attribute protein mass spectrometry methods. This position will also emphasize mass spectrometric method development and application for product characterization, including primary structure / glycan structure elucidation, determination of product purity profiles, product attribute criticality and target product profiles, process characterization and product testing. Generation of technical documents and technical presentations is required as well as assistance in the preparation of relevant sections of regulatory documents. Additional responsibilities include keeping current with field of expertise, including literature and technology development. This position is also responsible for providing scientific results that support the generation of publications, patents and regulatory submissions, participating in recruiting and candidate evaluation, and monitoring and analyzing competitive scientific knowledge from external sources.
Basic Qualifications Preferred Qualifications |
How to Apply
- Posted by: admin
- Company: Amgen
- State: Massachusetts
- Location: Cambridge, Massachusetts, United States
- Job type: Full-Time
- Salary:
- Job category: research - science
- Tags: Research Associate - Research Scientist - Scientist
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