Engineer, Process Development

Career Category
Engineering
Job Description

HOW MIGHT YOU DEFY IMAGINATION?

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

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Engineer, Process Development

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What you will do

In this role you will be a part of the Process Development Drug Substance Technology group at Amgen's FleX Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.

• Apply a fundamental understanding of Downstream bioprocessing to support biologics technology transfer, process validation, and plant start-up

• Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management

• Ensure safety and compliance of process development activities

• Provide process on floor process support as required

• Provide support for regulatory filing, inspection, and other CMC activities

Responsibilities:

• Apply fundamental scientific principles to Biopharmaceutical manufacturing processes (downstream purification) in the development of process improvements, facility adaptations, and new process operations.

• Provide technical and on-the-floor support to assist in the troubleshooting of clinical and commercial drug substance manufacturing.

• Support the GMP manufacturing process evaluations and investigations.

• Develop novel mammalian next generation technologies to increase yield, process robustness, and enable new unit operations.

Basic Qualifications:

• High school diploma / GED and 8 years of process science or technology transfer experience

• Associate's degree and 6 years of process science or technology transfer experience

• Bachelor's degree and 4 years of process science or technology transfer experience

• Master's degree

Preferred Qualifications:

• 2 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.

• Chromatography, ultrafiltration and normal flow filtration operations experience

• Chemical engineering principles for the scale up of unit operations from bench scale to commercial scale.

• 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

• Experience developing and managing team training workflows and strategy.

• 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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Salary Range
95,914.00 USD - 116,069.00 USD