Process Development Scientist - Pivotal Attribute Sciences

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Process Development Scientist - Pivotal Attribute Sciences

Live

What you will do

Amgens Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organization's focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs), live oncolytic viruses, and synthetic medicines. Located in our Thousand Oaks, CA office, the PD Scientist will work supporting product characterization and method development for clinical candidate molecules in the pivotal stage of development.

Key Responsibilities:

• Deep understanding of product quality attributes and methodology to measure attributes
• Development and qualification of analytical methods (HPLC/UPLC, CE and Mass Spec) to support clinical candidate molecules in the pivotal stage of development
• Support drug substance and drug product process development and protein characterization, collect analytical data to be used for regulatory submissions, and participate in technology transfer activities
• Communicate (verbal and in written) scientific concepts and results
• Follow protocols and procedures, maintain accurate records in an electronic lab notebook, and generate quality data for use in drug development and regulatory filings
• Work collaboratively with other scientists on multidisciplinary teams
• Work independently in advancing projects and studies within required deadlines.
• Keep current with field of expertise, participate and advance drug development, technologies and information services within Amgen

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The highly motivated professional we seek is a Scientist with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 4 years of pharmaceutical-biotechnology and/or CRO industry and/or Scientific experience OR
• Bachelors degree and 6 years of pharmaceutical-biotechnology and/or CRO industry and/or Scientific experience

Preferred Qualifications:

• Ph.D. in Analytical Chemistry, biochemistry, chemistry, chemical engineering or other life science area
• 2 or more years post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development.
• Strong lab skills to design and execute scientific experiments, interpretation of complex data and deliver results
• Strong expertise in analytical method development, qualification and trouble-shooting for using HPLC/UPLC, CE and mass spectrometry etc.
• 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.
• Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects

Thrive

Some of the vast rewards of working here

• As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.