Career Category

Job Description

Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients’ lives?

We have a position available for an Engineer to join our Purification Process engineering team at our Rhode Island Site. The Engineer will be part of a team focused on bioprocess purification process optimization, drug substance manufacturing support and new product introductions. The site operates two multi-product facilities that manufacture a range of innovative biologic and bio-similar medicines. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility.

Responsibilities include:

Apply a fundamental understanding of protein purification unit operations to support commercial manufacturing processes:

• Large Scale Column 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 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.

Basic Qualifications

Master’s degree

Or

Bachelors and 2 years of Process Development or Operations experience

Or

Associate’s degree and 6 years of Process Development or Operations experience

Or

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

Preferred Qualifications

• 1+ years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.
• Possess basic understanding of regulatory and cGMP requirement
• Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
• Excellent written and verbal communication
• Demonstrated ability to work under moderate direction.
• Able to analyze and interpret data
• Be a self-starter with the ability to take on several projects at one time

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.