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The Pivotal Synthetic Drug Product group of the Drug Product Technologies (DPT) department of Amgen at Thousand Oaks, CA is seeking an enthusiastic, highly motivated, and team-oriented scientist for the position of Scientist. In this role, the scientist will serve as the Formulation Development representative on small molecule development teams, providing functional area expertise during the development of pivotal clinical programs. The individual will effectively interface within the DPT department and with external functions, such as Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Toxicology, Pharmacokinetics and Drug Metabolism, Clinical Development, Biostatistics, etc.
The scientist will primarily design and execute formulation and processing experiments for solid oral dosage forms leading to the best possible platform formulations and/or enabling formulations to achieve robust regulatory packages. It is expected that the scientist will conduct technology transfer to pivotal and or commercial sites. Independent formulation research on enabling technologies and or unique delivery systems is highly desirable. Knowledge and experience with development of small molecule parenteral formulations and/or aseptic processing experience is a plus.
Basic Qualifications
Doctorate degree
Master's degree and 4 years of Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering experience
Bachelor's degree and 6 years of Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering experience
Preferred Qualifications
  • Ph.D. in Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering or other relevant scientific field with emphasis on oral solid dosage forms and unique delivery systems.
  • Experience as a Formulation Development representative serving on interdisciplinary and multidisciplinary teams.
  • Experience in authoring regulatory documentation (IND, IMPD, MAA, etc.).
  • Experience with parenteral formulations and aseptic processes or unique technologies (eg. spray drying, modified release formulations, etc.) is also preferred.
  • In depth understanding of typical unit operations for the manufacture of oral solid dosage forms (i.e. granulation, drying, milling, blending, compression, etc.). Experience in optimization and scale-up studies is a plus.
  • Excellent interpersonal and verbal/written communication skills that enable effective management and resolution of complex project-related issues involving collaborations with multiple functional areas is a must.
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 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.

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