26 days old

Associate, Process Development - Pivotal Drug Product

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    134608256
Amgen

Job ID: R-117134
Location: Thousand Oaks, CA, US

HOW MIGHT YOU DEFY IMAGINATION?

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

ASSOCIATE, PROCESS DEVELOPMENT - PIVOTAL DRUG PRODUCT

Live

What you will do

Let's do this. Let's change the world. In this vital role you will be to provide support for Amgen's biologics drug product and process design, commercialization and lifecycle management. The Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. In addition to performing process characterization and formulation studies, this role will also focus on data analytics, statistical modeling, and data visualization technologies. The Associate will integrate and utilize platform capabilities, prior product knowledge, and data analytics/visualization to advance Amgen products and ensure success through the commercialization process. This role will be based in our Thousand Oaks, CA headquarters.

Responsibilities include:

  • Participate in the planning, design, execution, and documentation of studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics.
  • Perform analytical characterization supporting attribute and stability assessments using chromatography and biophysical characterization tools.
  • Build a wide range of data and analytics solutions for Amgen Platforms using commercial dashboarding tools such as TIBCO Spotfire, MS Smartsheet
  • Assist with Platforms Sharepoint webpage design, updates and maintenance
  • Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
  • Create visualizations to enable business application of data analysis.
  • Explore and evaluate new digital tools and techniques to improve the team's developmental and operational capabilities
  • As needed, provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
  • Deliver progress reports and presentations to ensure management awareness and engagement of the 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. The biotech/pharma associate professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications

Bachelor's degree

OR

Associate degree and 4 years of scientific experience

Or

High school diploma / GED and 6 years of scientific experience

Preferred Qualifications

  • Bachelor's degree in Chemical Engineering, Biomedical Engineering, Chemistry, Biochemistry, or other relevant sciences
  • Demonstrated ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment
  • Basic understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality
  • Proficiency in at least one statistical software package (such as SIMCA or JMP)
  • Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function
  • Strong problem solving and effective cross-functional communication skills.
  • Demonstrated success working with diverse team members in a dynamic, cross-functional environment


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 Plan-comprising health, finance and wealth, work/life balance, and career benefits-with 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.

careers.amgen.com

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.

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.





PI134608256

Posted: 2021-04-21 Expires: 2021-05-23

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Associate, Process Development - Pivotal Drug Product

Amgen
Thousand Oaks, CA 91360

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