Skip to main content

This job has expired

You will need to login before you can apply for a job.

Process Development Principal Scientist Attribute Sciences

Employer
Amgen
Location
Thousand Oaks, California
Start date
Feb 29, 2024

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Process Development Principal Scientist

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be part of a global multidisciplinary group with responsibilities of leading the development of analytical methods for process-related impurities, formulation excipients, media, impurities, and raw materials that are used in manufacturing protein therapeutic drug products. Our group works end-to-end across process development, and you will contribute to programs from First in Human clinical trials through Commercialization, Marketing Application and post approval. You will also have opportunity to collaborate with cross-functional partners in drug substance, drug product, device, manufacturing, quality, and regulatory functions.

  • Lead the development and execution of state-of-the-art and fit-for-purpose analytical methods for excipients, process-related impurities, media, impurities, and raw materials.

  • Provide critical evaluation of analytical data and results to support process development in the areas of process-related impurities clearance, excipient quantification, impurity characterization, media and raw material analyses.

  • Author technical reports for process development, regulatory submissions, and investigations.

  • Lead method development, validation, and transfer to Amgen manufacturing sites around the world, and/or to external CRO/CMOs.

  • Monitor method performance metrics and address method performance issues.

  • Analyze and improve strategies and technologies by carefully examining and explaining scientific data to draw clear conclusions and giving guidance for future work.

  • Interact with key stake- and opinion-holders including external peers and regulatory agencies to drive Amgens science and strategy.

  • Mentor junior laboratory staff.

Win

What we expect of you

We are all different, yet we all make our unique contributions to serve patients. The self-starting and motivated professional we seek is a scientist with these qualifications.

Basic Qualifications:
  • Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of post-graduate laboratory experience OR

  • Masters degree and 5+ years of directly related experience OR

  • Bachelors degree and 7+ years of directly related experience

Preferred Qualifications:
  • Ph.D. in analytical chemistry, physical chemistry, biochemistry, chemistry, chemical engineering, material science, or other life science areas plus 3+ years of post-graduate experience in driving analytical deliverables for biopharmaceutical process and product development.

  • Direct and comprehensive experience and expertise in analytical techniques such as HPLC, ICP-MS, GC, IC, and biophysical techniques.

  • Experience with authoring and reviewing regulatory filings: IND, BLA/MA, NDA.

  • Knowledge and experience in analytical method development, validation, and transfer.

  • Knowledge in raw materials and material attributes, bioprocessing, protein purification, formulation development, process-related impurities and excipients characterization, organic chemistry, protein characterization.

  • Knowledge with process and product attributes including aggregation, particles, fill & finish, primary containers and delivery systems.

  • Knowledge in ICH guidelines, compendia monographs and methods, and cGMP.

  • Strong oral and written communication skills, including data visualization, presentations and authoring technical documents and scientific publications.

  • Strong problem-solving skills, organizational skills, and ability to collaborate effectively and work in teams and cross-functionally.

  • Proven ability to learn new analytical techniques and skills to solve complex analytical problems through innovative approaches and critical thinking.

  • Demonstrated diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach junior staff members.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

  • Stock-based long-term incentives

  • Award-winning time-off plans and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

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

careers.amgen.com

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 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Facebook  Social Icon - X Logo

Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert