Scientist - Drug Product Technologies
Amgen is currently seeking a Scientist in our Drug Product Technologies Department with a strong scientific background in Protein Formulation and Process Development.
The Scientist provides formulation and process development technical support to bring new parenteral drug products to Clinic, provide unique solutions to address chemical and physical stability, conducts major degradation pathway evaluations, process performance, and implementation of process improvement strategies. Cross-functional and cross-team collaborations are expected. Experience in developing and implementing emerging technologies is required.
- Develops drug product formulations, characterization processes models on drug substance freezing/thawing, formulation, filtration, filling vials/syringes/devices, lyophilization, visual inspection, and transportation, for biologic parenteral products, by applying strong scientific and engineering principles.
- Performs process technology transfers to Clinical sterile fill finish manufacturing sites both at Amgen and external (Contract Manufacturing) by providing process development expertise for clinical drug product processing in specific areas such as Sterile Processing, Equipment and Process Qualification and Environmental Monitoring.
- Performs product and process monitoring to identify and implement formulation and/or process improvements for current and new sterile operations.
- Participation in cross-functional teams working effectively in a highly matrixed team environment to enhance our understanding of protein behavior and stability.
Master's degree and 4 years of scientific experience
Bachelor's degree and 6 years of scientific experience