Process Development Scientist-Synthetics Pivotal Drug Product

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. The Scientist will conduct technology transfer to pivotal and/or commercial sites.

Basic Qualifications:

Doctorate degree or Doctorate degree completed by September 2019

OR

Master's degree and 4 years of Scientific experience

OR

Bachelor's degree and 6 years of Scientific experience

Preferred Qualifications:

Ph.D. in Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering, or other relevant scientific field with emphasis on solid-state systems and a good understanding of statistics

Excellent interpersonal and verbal/written communication skills that enable effective management and resolution of complex project-related issues involving collaborations with multiple functional areas

In depth understanding of typical unit operations for the manufacture of oral solid dosage forms (i.e. granulation, drying, milling, blending, compression, etc.). Experience on unique technologies (e.g., spray drying, modified release formulations, etc.)

Other experiences are Formulation Development lead serving on multidisciplinary matrix teams, authoring regulatory documentation (IND, IMPD, MA, etc.), and optimization and scale-up studies

Independent formulation research on enabling technologies and or unique delivery systems

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.