Senior Engineer/ Scientist, Drug Product Pilot Plant

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.

Senior Engineer/ Scientist, Drug Product Pilot Plant

Live

What you will do

Let's do this. Let's change the world. In this vital role you 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 maximize industry leading capabilities for robust, efficient product development and commercialization, and to advance next generation process technologies to support Amgen's drug product manufacturing network. B6 serves as an innovation incubator for new manufacturing technologies. This role is crucial for Amgen's success and it will be a key contributor to ensure we reliably supply medicines to our patients.

The Senior Engineer/ Scientist will provide technical leadership to Amgen's biologics, parenteral drug product, process design and commercialization. This role will lead off-line process characterization activities and partner with our global technology transfer team to transfer the process to clinical/ commercial fill finish lines with the aim of reducing or eliminating the onsite characterization work required. The candidate will also play a meaningful role in developing business cases for utilizing the pilot plant capabilities further to serve the network and manage/ operate the assets to perform process characterization, qualification of new primary containers, material generation for non-human use and technology advancement.

This position will require up to 20% of domestic and international travel.

Senior Engineer/ Scientist responsibilities include, but are not limited to, the following:

• Design, execute and document technical data packages related to drug product process design, development and characterization.
• Serve as subject matter expert in DP manufacturing technologies (e.g. filling, lyophilization) and work with global cross-functional teams for shared best practices and technical advancements across Amgen clinical and commercial fill-finish plants.
• Assist with managing the plant operations, identify needs for new scale-down models, work with vendors and subject matter experts to build them to serve diverse development and manufacturing network needs
• Lead and execute complex projects in a matrixed environment, including manufacturing, engineering, process development, quality, automation and IS, to ensure technical recommendations are aligned with business needs, agency guidelines and internal quality standards.
• Work with a team of engineers and individually to design, document and execute primary data packages related to new technology development, while demonstrating specific expertise in aseptic processing and unit operations characterization.
• Drive innovations in drug product process characterization and reduce the line time required for clinical/ commercial time on the line, required for onsite characterization activities
• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials.
• Assess risk, benefits and the economics of new processes and manufacturing technologies and ensure their robust performance through detailed research and rigorous technology evaluations in the drug product pilot plant.
• Run sophisticated fillers for generating materials for diverse use.
• Utilize strong written and verbal communicational skills. Author technical protocols, reports and present findings and project status.

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The Engineering professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications:

Doctoral degree

OR

Master's degree & 3 years relevant experience

OR

Bachelor's degree & 6 years relevant experience

OR

Associate's degree & 8 years relevant experience
Or

High school diploma or GED certification & 10 years relevant experience

Preferred Qualifications:

• Advanced degree in engineering, biotechnology, life sciences or related subject area
• demonstrated ability 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 multi-functional team environment, and act on dynamic information at a rapid pace
• Ability to independently craft 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
• Capable of coordinating and communicating sophisticated technical concepts to enable business decisions
• Leadership skills and/or experience in leading diverse multi-functional 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 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.

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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.

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.