PD Scientist Attribute Sciences Group Lead (Rapid Analytics)
- Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers ("BiTEs"), live oncolytic viruses, and synthetic medicines.
Located in our Cambridge, MA office, as an Attribute Sciences Group Lead of Rapid Analytics, the PD Scientist will lead an analytical team supporting drug substance and drug product commercial process design as well as product specific and compendial method troubleshooting and remediation for clinical candidate molecules in the pivotal stage of development.
Key responsibilities include:
- Oversee a team performing testing and characterization of protein products: Collaboratively design and execute studies, interpret results, author technical reports to support drug substance and drug product commercial process design
- Supervise the qualification, troubleshooting/remediation, and transfer of analytical methods to Quality Control.
- Closely collaborate with partner organizations during drug substance and drug product commercial process design and process validation studies to support marketing applications.
- Providing expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development.
- Inform the analytical target profile for the methods used to monitor product quality by managing assay control charts and tracking method performance.
Master's degree and 4 years of scientific experience
Bachelor's degree and 6 years of scientific experience
- Ph.D. in pharmaceutical science, chemistry, biology, biochemistry or related fields
- Strong scientific background in biologics method development and product characterization
- Ability to lead transversal project teams, previous managerial experience
- 5 years' experience in industrial analytical laboratories supporting method development and testing of commercial or clinical protein products
- Demonstrated proficiency in solving complex problems, ability to work independently, proactively seek outside resources and collaborate, self-starter and team player with strong leadership and decision-making skills capable of providing mentorship to junior staff
- Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects