Engineer Drug Product

Thousand Oaks, CA, US
Oct 15, 2020
Required Education
High School or equivalent
Position Type
Full time
The Engineer will be joining the B6 Drug Product Pilot Plant Operations team within Manufacturing and Clinical Supply organization in Amgen Process Development (Thousand Oaks, CA). The group's mission is to bring to bear industry leading pilot plant capabilities for robust, efficient product commercialization, and to advance next generation process technologies to support Amgen's drug product manufacturing network. This role is essential for Amgen's success and it will be a catalyst to ensure we reliably supply medicines to our patients.

Job responsibilities:
  • Design, execute and detail technical data packages related to drug product process design, development and characterization.
  • Identify needs for new scale-down models, work with vendors and domain experts to build them to serve diverse development and manufacturing network needs
  • Routinely run complex fillers for generating materials for diverse use.
  • Serve as subject matter expert in DP manufacturing technologies (e.g. filling, lyophilization) and work with global cross-functional teams for sharing best practices and technical advancements across Amgen clinical and commercial fill-finish plants.
  • Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials.
  • Participate in the cross functional meetings with process development, manufacturing, quality etc and represent B6.
  • Evaluate next generation technologies in pilot plant.
  • Perform tasks related to safety and compliance initiatives in the lab.
  • Travel domestically and internationally up to 10% of the time.

Basic Qualifications:

Master's Degree Engineering and/or Operations experience

Bachelor's Degree and 2 years of Engineering and/or Operations experience

Associate's degree and 6 years of Engineering and/or Operations experience

High school diploma/GED and 8 years of Engineering and/or Operations experience

Preferred Qualifications:
  • Advanced degree in engineering, biotechnology, life sciences or related subject area
  • 3+ years of relevant experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites
  • Advanced knowledge of biopharmaceutical manufacturing and business processes, and experience supporting GMP manufacturing operations
  • Knowledge of, and hands-on experience with various drug product technologies related to fill-finish process (freeze-thaw, filtration, filling, isolators, lyophilization, visual inspection operations etc.)
  • Ability to lead innovation, collaborate in a cross-functional team environment, and act on dynamic information at a rapid pace
  • Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports
  • Proficiency in technical problem solving, critical thinking, and the delivery of technical solutions with limited oversight

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.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.