Sr Scientist - Pre- Pivotal Drug Product Technologies
Amgen is currently seeking a Senior Scientist in Pre- Pivotal Drug Product Technologies Department with a strong scientific background in Protein Biochemistry.
Developing a suitable formulation that balances the needs of product quality/stability with drug product manufacturing and drug delivery is crucial for Amgen's success. As such, the Senior Scientist position is expected to be a key contributor to Amgen's drug product development. The Senior Scientist will lead the development of drug product formulation with an emphasis on experimental designs that will provide predictive models for formulation development. This position will identify current gaps in Amgen's tools and technology to the optimization of protein therapeutics for stabilization towards alternative modes of delivery and storage is of critical importance in the development of human therapeutics. Cross-functional and cross-team collaborations are expected. Experience in developing and implementing emerging technologies is required.
* An opportunity for a highly motivated and creative candidate to develop, advance and apply protein biochemistry/polymer technologies to drug delivery challenges.
* Drive continuous improvement in our knowledge of drug product development through technological innovation and application of experimental findings.
* Responsible for development and exploration of new technologies for different modalities such as fusion proteins, Mab fragments, RNA based drugs.
* Deliver progress reports, presentations, expectations include both internal and external presentation of scientific data with an eventual external publication/patent track record.
* Author technical protocols, reports, Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
* Participation in global cross-functional teams working effectively in a highly matrixed team environment to enhance our understanding of protein behavior
* Doctorate degree and 2 years of scientific experience
* Master's degree and 5 years of scientific experience
* Bachelor's degree and 7 years of scientific experience
* Advanced degree in (ideally PhD) in Pharmaceutics, Biotechnology, Biochemistry, Physical Biochemistry or related discipline with a minimum of 4 years of experience in Pharmaceuticals/biotechnology
* Advanced knowledge and hands on experience in Bio-physical and Molecular Biology techniques
* Strong independent problem solving and communication skills
* Demonstrated background in protein characterization, stability and experience in development of parenteral control release delivery systems is a plus
* Publication background commensurate with Protein Biochemistry.
* Advanced understanding of predictive methods, protein stability and solubility
* Demonstrated background in modeling and prediction of protein:protein interactions and protein behavior
* Demonstrated ability to learn and act on dynamic information at a rapid pace.