PD Attribute Sciences Senior Associate
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will doLets do this! Lets change the world! There an exciting career opportunity to join the Commercial Attribute Sciences team at the Amgen Rhode Island site. In this role as a Senior Associate, you will:Execute routine and characterization testing using multiple analytical methods and technologies to support commercial and NPI 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 remediationsSupport process improvements, including analytical comparability, small-scale model supportSupport site Forensics team in commercial manufacturing and PD investigations.
Bachelors degree and 2 years of Scientific or Operations experience
- 3+ 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 one or more of the following: HPLC, CE, ELISA, and/or other techniques
- 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 working in a matrix environment
- Experience in data analysis, statistical analysis, method qualifications/transfers
- Experience in applying troubleshooting and investigation methodologies for problem solving
- Familiarity with biopharmaceutical manufacturing processes
- Familiarity with forensics analysis
- Familiarity with regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements
- Strong technical writing and verbal communication skills
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.