Process Development Scientist
In this vital role you will contribute to Amgens diverse process development portfolio of therapeutic modalities with a focus on understanding process and product properties of large molecule drug candidates and assessing the quality attributes of protein therapeutics being developed across multiple therapeutic areas in Amgens pipeline. Collaborate cross-functionally to drive the efficient transfer of technologies and to ensure appropriate delivery of procedures and processes. Responsible for analytical leadership of pre-pivotal programs, Scientific and technical expertise to advance the pre-pivotal portfolio Lead development and implementation of sophisticated analytical techniques.
- Routinely craft experiments that lead to a fundamental understanding of a therapeutic proteins attributes and stability characteristics.
- Development and optimization of analytical methods (HPLC/UPLC, CE and mass spec) to support lead candidate selection for different modalities at Dev MA, to improve method performance and to increase efficiency and throughput at pre-pivotal stage.
- Investigation of method performance, reliability, and evaluation of impact of proposed changes.
- Deep understanding of product quality attributes and methodology to measure attributes, and to ensure proper control strategy.
- Optimally function as an Attribute Sciences representative on project teams and participate in technology transfer activities
- Support drug substance and drug product process development, and protein characterization
- Authoring regulatory documents. Understanding of regulatory expectations for analytical methods, control and stability strategy and comparability.
- Work collaboratively with other scientists on multidisciplinary teams
- Keep current with field of expertise and evaluate emerging analytical technology
- Doctorate degree OR
- Masters degree and 4 years of directly related life science experience OR
- Bachelors degree and 6 years of directly related life science experience
- Ph.D. in biochemistry, chemistry or other life science area plus 4 or more years of industry experience.
- Strong lab skills to design and execute scientific experiments, interpretation of complex data and deliver results
- Strong expertise in analytical method development, validation and trouble-shooting for using HPLC/UPLC, CE and mass spectrometry etc.
- Strong proven experience in separation sciences, protein chemistry and/or mass spectrometry.
- Familiarity with commonly observed product quality attributes associated with therapeutic proteins (such as fragmentation, deamidation, oxidation, partial reduction etc.), and their characterization and quantification tools
- Prior experience authoring or contributing to regulatory filings.
- Work independently in advancing projects and studies within required deadlines.
- Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary environment.
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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.