Job ID: R-91925 Location: Thousand Oaks, CA, US 91360
Amgen is currently seeking a Scientist, Analytical Chemist in our Pivotal Attribute Sciences (AS) Department. The Scientist, Analytical Chemist will be based out of Amgen's Thousand Oaks, California location and will report to the Process Development Scientist/Pivotal AS. This group is responsible for pivotal phase analytical development, including method development, method validation, method transfer, process and product development support, and Good Manufacturing Practices (GMP) testing of early phase drug substances and drug products. The Scientist, Analytical Chemist will work closely with a team of other analytical chemists, organic chemists and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for synthetic manufacturing processes and synthetic products. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success from study through to marketing application.
At Amgen, our mission is simple: to serve patients. Our Thousand Oaks, California locations provides essential services that enable us to better pursue this mission. This state-of-the-art center serves as a base for finance, information systems, and human resources professionals to make a meaningful impact at one of the world's leading biotechnology companies.
Identifying and characterizing attributes of therapeutic synthetic molecules
Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs.
Develop and apply novel sample preparation and analytical methods for analysis of therapeutic synthetic molecules with emphasis on chromatography and mass spectrometry (LC-MS/MS)
Collaborate closely with drug substance and drug product process development colleagues.
Manage activities at contract manufacturing and testing sites.
May lead and develop a small group of scientists.
Master's degree and 4 years of analytical chemistry experience
Bachelor's degree and 6 years of analytical chemistry experience
•PhD in Analytical Chemistry or Biochemistry with emphasis in analytical chemistry, preferably with mass spectrometry experience
•2+ year's post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development.
•Experience in a wide variety of structure elucidation and physicochemical techniques including chromatography, mass spectrometry, UV, NMR, FTIR, particle size determination, crystal characterization, etc.
•Strong understanding of small molecule analysis, solid-state characterization and structure elucidation guided and informed by knowledge of organic chemistry.
•Developing and implementing methods for in-process testing, release and stability testing.
•Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products.
•Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
•Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner
•Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage deliverable's against timelines
•Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile
•Works well in cross-functional teams, and across various geographic locations in different time zones
•Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
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.
If 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.