Amgen Senior Manager Commercial Attribute Sciences in Singapore, Singapore
The Principal Scientist, Process Development will lead an analytical group of approximately 4 to 5 scientists based in the Amgen Singapore Manufacturing (ASM) facility, and will be responsible to drive product quality attribute understanding and process development support of commercial Biological and Synthetic products manufactured at the site. The Principal Scientist will work closely and collaborate with leaders from key functions within Process Development, Manufacturing and Quality at the facility. The analytical group based in ASM, is responsible to sustain attribute focused analytical methods, support small scale model and forensics studies, and participate in method transfer activities. The group provides scientific support for analytical methods run in quality control laboratory, and manufacturing, performs troubleshooting of method performance, and participates in the writing of responses to health authority questions over the commercial lifecycle of the products manufactured at the facility.
Doctorate degree & 2 years of relevant Scientific experience OR
Master’s degree & 6 years of relevant Scientific experience OR
Bachelor’s degree & 8 years of relevant Scientific experience AND
Minimum 4 years of industry experience in the successful development and implementation of analytical methods using state of the art analytical technologies.
· 10 years of relevant scientific working experience for applying analytical methods/technologies used in biologics and small molecule development.
· PhD in biological sciences, biochemistry or analytical sciences
· Deep understanding of product quality attributes control strategies
· Experience in development of quantitative mass spectrometry methods for characterization, quality control testing and disposition of biologics, is highly desired.
· Demonstrated experience working in matrix environment to support overall CMC development
· Strong communication, collaboration and team building skills
· Strong working knowledge of regulatory expectations related to analytical control strategies
· Familiarity with applicable worldwide regulatory requirements.
· Knowledge of Validation Lifecycle Approach.
· Excellent technical writing and verbal communication skills.
· Experience in requisite authoring or regulatory submissions.
· Provides clear and consistent vision and direction to team.
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.