Engineer – Downstream Process Development

Engineer – Downstream Process Development

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of a team focused on bioprocess purification process 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. Interested candidates should possess downstream expertise.

• 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.
• Complete 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 career development in areas of leadership, collaboration, communication and to develop a 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 dedicated professional we seek is detail oriented with these qualifications.

Basic Qualifications:

• High school/GED + 4 years engineering work experience OR
• Associate’s + 2 years engineering work experience OR
• Bachelor’s + 6 months engineering work experience
• Master's

Preferred Qualifications:

• 1-2 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 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
• Excellent written and verbal communication
• 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