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Senior Scientist, Process Reagents and Excipients

Company: Amgen
Location: Thousand Oaks
Posted on: March 18, 2020

Job Description:

Amgen is seeking a Senior Scientist, Process Reagents and Excipients to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more: The Senior Scientist will lead a dynamic team to develop and provide analytical support for process reagents and excipients of Amgen's therapeutics. This will involve working on a wide range of bioprocesses and modalities including antibodies and engineered proteins to provide end-to-end support of Amgen's biotherapeutics portfolio.Day to Day Duties:Leading a team of staff to provide analytical support for process reagents clearance and excipients characterizationServing as functional area owner and subject matter expert cross-functionallyResponsibilities:Leading the team to develop and execute state-of-the-art and fit-for-purpose analytical methods for excipients and process reagents analysisProviding critical evaluation of analytical data and results to support process development in the areas of process reagent clearance evaluation and excipient quantificationAuthoring technical reports for process development, regulatory submissions, and investigationsSupporting method development, qualification, and transfer; monitoring method performance metrics and addressing method performance issuesDefining and optimizing strategies and technologies for Amgen's excipient and process reagents characterization and reagent clearance evaluationInteracting with key stake- and opinion-holders including external peers and regulatory agencies to drive Amgen's science strategyBasic Qualifications:Doctorate degree and 2 years of directly relevant scientific experienceOrMaster's degree and 5 years of directly relevant scientific experienceOrBachelor's degree and 7 years of directly relevant scientific experienceDesired Qualifications:Technical experience and expertise: expertise and direct experience with analytical techniques for the quantitative determination of excipients and reagents, assay development (method optimization, qualification, validation, troubleshooting). Knowledge and experience in ICH Impurities Guideline a plus, experience in regulatory filings a plus, in-depth experience with chromatography a plus, knowledge and experience in protein purification process and characterization a plus, experience with raw materials characterization a plus, experience in resource management a plus, PhD in Analytical chemistry/Biotechnology/Biochemistry or similar disciplines a plus.Direct supervisory experience a plus.Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.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.

Keywords: Amgen, Thousand Oaks , Senior Scientist, Process Reagents and Excipients, Other , Thousand Oaks, California

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