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Process Development Sr Associate
at Amgen Inc.
Career CategoryProcess Development
Do you want to help shape the future of biopharmaceutical manufacturing? We have an opening for a Senior Associate to join the Commercial Attribute Sciences group at our Rhode Island site.
This is an analytical scientific position supporting late stage/ commercial manufacturing of biopharmaceutical products. The Sr. Associate is aligned with multiple functional areas and is tasked with testing, troubleshooting, and investigating.
Key Responsibilities Include:
- 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 remediations
- Support process improvements, including analytical comparability, small-scale model support
- Support site Forensics team in commercial manufacturing and PD investigations.
Bachelor’s 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
Amgen strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives. In everything we do, we aim to fulfill our mission to serve patients. And every step of the way, we are guided by the values that define us.
Amgen leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If 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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.