Analytical Chemist - Process Development Senior Scientist

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Analytical Chemist - Process Development Senior Scientist

What you will do

Let’s do this! Let’s change the world! Amgen is currently seeking a Sr. Scientist - Analytical Chemist in our Pre-Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for early phase analytical development, including method development, method validation, method transfer, process and product development support, and GMP testing of early phase drug substances and drug products. The individual 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 early phase synthetic programs. The Sr. Scientist will integrate and successfully use platform and prior product knowledge to advance Amgen practices and ensure success from clinical candidate selection to IND filings. The Sr. Scientist should have strong analytical chemistry and communication skills.

Key Responsibilities:

• Analytical method development, validation and troubleshooting for small molecule drug substances and drug products and in-process testing.

• Define analytical control strategies and implement methodologies for development of early phase clinical programs.

• Collaborate 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] OR

• Master’s degree and 3 years of scientific experience OR

• Bachelor’s degree and 5 years of scientific experience

Preferred Qualifications:

• PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering

• Experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development.

• Strong understanding of small molecule analysis, structure elucidation, and solid-state characterization guided and informed by knowledge of organic chemistry.

• Experience in a wide variety of structure elucidation and physiochemical techniques including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.

• Ability to develop and implement methods for in-process, 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, early phase development, 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, handle deliverables 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 d