Process Development Senior Bioprocess Engineer - Amgen

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 Senior Bioprocess Engineer

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 downstream (purification, chromatography) expertise.

• Apply a fundamental understanding of protein purification operations to support technology transfer and commercial manufacturing processes:
• Large Scale Chromatography
• Tangential flow filtration
• Normal Flow Filtration
• Virus Inactivation and Virus Filtration
• 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, teamwork, collaboration, communication and to develop network influence by partnering with colleagues in Process Development, Manufacturing, as well as Quality and Information Systems.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is an individual with these qualifications.

• High school diploma / GED and 10 years of Engineering or Operations experience OR
• Associates degree and 8 years of Engineering or Operations experience Or
• Bachelors degree and 4 years of Engineering or Operations experience Or
• Masters degree and 2 years of Engineering or Operations experience Or
• Doctorate degree

• 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
• Excellent written and verbal communication
• 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

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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

for a career that defies imagination

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

careers.amgen.com

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.