Process Development Bioprocess Senior Engineer

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career.

How will you put your skills, experience and passion to work toward your goals?

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.

Come do your best work alongside other innovative, driven professionals in this meaningful role.

Process Development Bioprocess Senior Engineer Live What you will do Lets do this Lets change the world In this vital role, you will be part of a team focused on bioprocess optimization, drug substance manufacturing support, and new product introductions.

The site operates two multiproduct facilities that manufacture a range of innovative biologic and biosimilar medicines.

This role will be immersed in all aspects of operations in a commercial bulk drug substance facility.

Ideal candidates should possess upstream process knowledge, specifically mammalian cell culture.

Responsibilities include: Apply a fundamental understanding of mammalian cell culture operations to support technology transfer and commercial manufacturing processes including: Scale up of cell culture, Single Use Bioreactors, Perfusion and Harvest technologies.

Use comprehensive understanding of chemical engineering principles for the scale up of unit operations from bench to commercial scale.

Provide technical leadership in solving clinical and commercial drug substance process issues involving equipment, scale, and raw materials.

Evaluate process capabilities to develop and implement process and yield improvement opportunities.

Partner with the Process Development laboratories to design experimentation to support process scale up.

Perform technical review of data, and author and review GMP documentation.

Execute technology transfer projects to support Amgen Network initiatives.

Provide floor support during clinical and validation runs.

The Sr.

Engineer will be encouraged to keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings.

This role provides a great opportunity for significant career development in areas of leadership, partnership, collaboration, communication and to develop network influence by partnering with colleagues in Process Development, Manufacturing, as well as Quality and Information Systems.

Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.

The self-motivated professional we seek is an excellent communicator with these qualifications.

Basic Qualifications: High School diploma/GED and 12 years of Engineering or Operations experience OR Associates degree and 10 years of Engineering or Operations experience OR Bachelors degree and 5 years of Engineering or Operations experience OR Masters degree and 3 years of Engineering or Operations experience OR Doctorate degree Preferred Qualifications: 6 years of experience in drug substance process development, characterization and/or commercial process support Possess advanced understanding of regulatory and cGMP requirements Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements Able to manage project resources and elevate relevant issues to project lead and line management Able to build and maintain high-performing, multi-functional partnerships and to lead matrix teams to advance complex projects to completion Demonstrated ability to work under minimal direction Be able to multi-task and function in a dynamic environment Thrive Some of the vast rewards of working here 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.

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.

careers.amgen.com 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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.

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