Live 

What you will do 

Let’s do this! Let’s change the world!  There an exciting career opportunity to join the Commercial Attribute Sciences team within the Process Development organization at the Amgen Rhode Island site.  In this role as a Scientist, you will: 

• Lead a team of scientists to provide technical oversight in support of method related testing challenges, incoming method transfer and commercial investigations spanning various analytical platforms which may include chromatography, CE, DNA, and immunoassays used to test diverse modalities.  

• Schedule and prioritize work for the team across a wide range of customers. 

• Responsible for supporting the implementation of new analytical technology, incoming tech transfer, analytical support for the Drug Substance Technology group. 

• Apply established platform approaches and problem-solving skills to rapidly tackle challenges spanning various analytical platforms 

• Interact and collaborate with multiple functional areas in matrix environment, both at site and network levels. 

• Interpret results, author and review technical reports and assessments. 

• Work closely with process engineers and quality control laboratories to generate and interpret analytical data to provide guidance around process understanding and control 

• Support process improvements, including analytical comparability, small-scale model support 

• Providing expertise and evaluation of Amgen’s platform and analytical technologies, helping to drive innovation and efficiency within Process Development. 

• Other duties include maintenance of electronic notebook records of experimental data, participation in authoring of technical protocols and reports, and presentation of results in internal meetings 

• Support career development and mentor staff. 

• Keep current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities. 

Win

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 a collaborative partner with these qualifications.

Basic Qualifications: 

Doctorate degree  OR 

• PhD in Biochemistry, Biomedical, Life Sciences or closely related field  

• 5+ years of scientific experience providing and driving analytical deliverables for biopharmaceutical processes and product development 

• Expert knowledge of analytical methods/technologies used in biologics for both routine and characterization testing using chromatography and mass spectrometry methods  

• Deep understanding of product quality attributes for biologics, their control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product 

• Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing. 

• Experience managing and transferring commercial production and test methods. 

• Experience in data analysis and statistical analysis 

• Experience in applying troubleshooting and investigation methodologies for problem solving 

• Experience with regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements 

• Familiarity with biopharmaceutical manufacturing processes 

• Familiarity with forensics analysis and investigations 

• Familiarity with lean concepts and 5S 

• Ability to independently manage and prioritize multiple tasks as well as work as part of a team 

• Motivated self-starter with excellent interpersonal and organizational skills 

• Demonstrated ability to deliver on complex and challenging objectives in defined timelines