Process Development Principal Scientist

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, mature, and team-oriented scientist for the position of Principal Scientist. In this leadership role, the Principal Scientist will supervise a group of junior scientists and will serve as Drug Product Team Lead (DPLT) providing creative functional area strategies, designing and executing DOE's during the development of pivotal and commercial ready programs. This Amgen's leader will lead cross-functional teams and guide junior scientists towards innovative and fast pace development approaches. The individual will effectively interface within the DPT department and with other Amgen functions, such as Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical Development, Biostatistics, etc.

In addition, this role will have proactive and effective interaction with external industrial (eg. IQ consortium) and academic groups (eg. University consortia).

Basic Qualifications:

Doctorate degree and 6 years of scientific experience

OR

Master's degree and 8 years of scientific experience

OR

Bachelor's degree and 10 years of scientific experience

Preferred Qualifications:

Ph.D. in Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering, or other relevant scientific fields with approximately 8+ years of experience in pharmaceutical industry with emphasis, but not limited to oral solid dosage forms.

Managerial experience.

In depth understanding of unit operations for the manufacture of oral solid dosage forms

Experience on parenteral and or pediatric formulations, and unique dosage forms

Experience in optimization and scale-up studies using QbD principles

Experience interacting with Contract Research/Manufacturing Organizations

Experience in authoring regulatory documentation (IND, MA, etc.) and interacting with regulatory authorities.

Experience on unique technologies (e.g., spray drying, hot melt extrusion, controlled release formulations, etc.) is preferred.

Design, execution and conduction of independent formulation research.

A solid publication record.

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

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.