Process Development Senior Associate

HOW MIGHT YOU DEFY IMAGINATION?

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.

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be the liaison to our customers by providing clinical knowledge of our products to medical professionals.

Amgen's medicines treat serious illnesses and our research address diseases with a limited number of treatment options. With a robust and differentiated pipeline, Amgen remains committed to advancing science to dramatically improve people's lives.

Based in Thousand Oaks, CA, the role of Sr. Associate in Pre-Pivotal Drug Product Technologies will be to provide support for Amgens biologics drug product and process design and FIH development. The Sr. Associate will work closely with a team of scientists and engineers responsible for the technical aspects of Amgens drug product and process development. In addition to performing process characterization and formulation studies, this role will also focus on development of streamlined processes for molecule assessment, formulation screening, and data analytics.

Responsibilities include:

• Participate in the planning, design, execution, and documentation of studies related to bispecific drug product design, formulation development, and process development in support of FIH development of bispecific biologics.
• Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND application submissions.
• Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
• Problem solving related to bispecific protein stability and viscosity using biophysical characterization techniques.
• Engagement in technology development activities related to drug delivery advancement.
• Participate in global cross-functional teams working effectively in a highly matrixed team environment to progress product development.
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications

Masters degree in related scientific discipline

Or

Bachelors degree in related scientific discipline and 2 years of scientific experience

Preferred Qualifications

Masters degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related discipline

2+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, and analytical characterization of proteins.

Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality

Proficiency with electronic notebook systems is a plus

Experience with data visualization tools

Strong problem solving and effective cross-functional communication skills.

Proven ability to learn and act on dynamic information at a rapid pace.

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

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.

Amgen is a Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients

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.

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.