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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Process Development Senior Scientist – Product and Reagent Attributes

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the group that provides attribute understanding, control, and analytical methods in the areas of particles and protein aggregates. You will have opportunities to collaborate with and influence cross-functional partners in drug substance, drug product, device, manufacturing, quality, and regulatory functions.

• Be the thought and strategy leader in the areas of particles and protein aggregates, including attribute understanding, control, and analytical methods and technologies; provide the vision for and drive towards the ideal future state.
• Lead the AS Drug Product Attributes team to provide scientific leadership, technical expertise, and analytical support to customer functions including Drug Substance, Drug Product, Primary Containers and Devices, Quality Control, and Product Quality.
• Design and implement experiments using aggregate/particle analytical techniques such as SEC, FFF, Light Obscuration, Light Scattering, Dynamic Imaging Analysis to development methods or generate data; provide results to support product development, regulatory submissions, RTQs, scientific publications, and patents.
• Enable method validation and transfer to Amgen manufacturing sites around the world, and/or to external CRO/CMOs.
• Bring Innovation with a positive approach, champion new insights and initiatives, and drive the evolution of Amgen’s platform in the areas of expertise.
• Collaborate with other scientists and keep current with both the literature and technology associated with the field of expertise.
• Participate in external scientific engagements to showcase Amgen’s science and innovation; influence and impact the field.
• Manage and mentor junior team members; coach and provide career and scientific advice to individuals across work groups / project teams.

Win

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 2 years of directly related experience OR
• Master’s degree and 5 years of directly related experience OR
• Bachelor’s degree and 7 years of directly related experience

Preferred Qualifications:

• Masters or Ph.D. in chemistry, biochemistry, analytical chemistry, physical chemistry, chemical engineering, or other science areas plus 5+ years of post-graduate experience
• Scientist with 5+ years of experience in driving particles attribute understanding and analytical deliverables for biopharmaceutical process and product development
• Extensive knowledge and expertise in the areas of protein aggregation, particulation, and analytical technologies for end-to-end characterization of aggregates and particles
• Strong knowledge and understanding in bioprocessing, formulation, primary containers and delivery systems, protein higher order structure, process reagents and excipients, impurities, and raw materials
• Strong knowledge and experience in characterization of nano-particles, sub-micron particles, sub-visible particles, visible particles, and particles of different origins such as protein aggregates, silicone oil droplet, and random-sources particles
• Direct experience and expertise in drug product and material physical attributes and characterization
• Demonstrated knowledge and experience in ICH guidelines, compendia monographs and methods, and cGMP
• Demonstrated knowledge and experience in analytical method development, qualification, validation, and transfer
• Excellent communication skills, problem-solving skills, organizational skills, and ability to collaborate effectively and work in teams
• Demonstrated leadership skills and experience in managing teams and deliverables
• Experience in collaborating with industrial peers, consortium, and regulatory bodies

Thrive

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
• A 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

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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