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 Senior Associate Scientist, you will: 

• Apply established platform approaches and problem-solving skills to rapidly tackle challenges with an emphasis on a variety of chromatographic systems (Agilent and Waters HPLCs and UHPLCs) and mass spectrometry methods (LC-MS/MS).  

• Execute characterization testing using multiple analytical methods and technologies to support commercial and process development programs. 

• 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. 

• Support technology and method lifecycle management, including method transfers, qualifications, improvements, trending and remediations.  Serve as an analytical subject matter expert to support investigations carried out by other functional areas. 

• 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 

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.

Bachelor’s degree and 5 years of Scientific or Operations experience 

Preferred Qualifications: 

• 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 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 

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

• Experience working with electronic lab notebook (ELN) 

• Experience following Standard Operating Procedures within a laboratory setting 

• Motivated self-starter with excellent interpersonal and organizational skills 

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