Process Development Scientist

Amgen is currently seeking a Scientist in our Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for late-phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of late-phase drug substances and drug products.

The Scientist will work closely with a team of analysts and scientists responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes in product and process for late phase synthetic programs. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success from clinical candidate selection to IND/NDA filings.

Key Responsibilities:

• Define analytical control strategies and implement methodologies for development of late phase clinical programs.
• Interpret results, author technical protocols, reports, analytical method descriptions and analytical chemistry, Manufacturing, and Contros (CMC) sections in regulatory documents
• Collaborate closely with drug substance and drug product process development colleagues.
• Manage activities at contract manufacturing and testing sites.

Educations Qualifications:

• 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

Preferred Qualifications:

• PhD in Analytical Chemistry, Organic Chemistry, or Biochemistry.
• Strong hands-on experience with mass spectrometry and fundamental understanding of its use for structure elucidation and attribute characterization.
• Familiarity with Thermo mass spectrometers, Agilent and Waters LC systems and corresponding software such as Chromeleon and Empower
• Familiarity with mass spectrometry data processing software (BioPharma Finder, Xcalibur, Skyline)
• Experience in a wide variety of structure elucidation and physicochemical techniques including mass spectrometry, UV, chromatography, NMR, etc.
• Developing and implementing methods for in-process testing, release and stability testing.
• 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
• Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, early phase development, etc.
• Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner

Join Us

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.