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HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility focused on medical device assembly and packaging of injectable medicines. When completed, the Advanced Assembly and Final Product Operation facility will not only feature the best in-class assembly and packaging 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.

Process Development Scientist: New Albany

Live

What you will do

Let’s do this. Let’s change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.

Based in New Albany, Ohio, the site of Amgen’s new advanced product assembly and packaging plant, this role will conceive, design, implement and complete specific scientific experiments, which contribute to the successful completion of goals and/or projects. Primary focus of these projects will be to: conceive and design, implement or evaluate, and interpret experimental strategies.

Responsibilities:

• Provide characterization of process optimization strategies and/or solving problems of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
• Function as a technical expert to equipment or systems regarding troubleshooting operations including; active participation in daily operations to resolve complex issues and/or meeting schedules.
• As the Domain Expert, ensure successful completion of a variety technical projects including New Product Introductions.
• Partner with research, manufacturing, maintenance, engineering, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
• Provide guidance to new processes to generate robust and reliable data
• Ensure that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations
• Support and/or lead new product introduction and/or tech transfer activities for the Drug Product operations.
• Design, monitor or conduct experimental strategies or projects which significantly contribute to attaining high priority goals
• Apply technical principles, theories, and concepts in the development of new principles and concepts.
• Provide data analysis and interpretation and assess impact of the data on the project.
• Conduct scientific research/investigation in areas of considerable scope and complexity; develop and implement new and novel protocols to address specific issues
• Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies
• Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents
• Interact effectively with variety of communication and working styles

Win

What we expect of you

Doctorate degree

Or

Master’s degree and 4 years of Process Development, Manufacturing, Operations, and/or Technical Services experience in GMP regulated industry

Or

Bachelor’s degree and 6 years of Process Development, Manufacturing, Operations, and/or Technical Services experience in GMP regulated industry

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a dynamic and flexible individual with these qualifications:

• Advanced degree in Life Sciences and/or Engineering
• Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of drug product operations
• Knowledge in combination products, tech transfers.
• Advanced laboratory work skills and experience with parenteral, process validation, process monitoring and/or process qualifications
• Ability to interpret and apply GLP's and GMPs and familiarity with documentation in a highly regulated environment
• Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
• Excellent organizational, project management, problem solving and technical writing capability
• Strong verbal and written communication and presentation skills
• Strong demonstration of interpersonal skills, including collaboration, influencing and facilitation
• Strong digital literacy, particularly in Word, Excel, Power Point

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we 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
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits —with 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.

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