Amgen

Process Development Principal Scientist

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 20, 2019
Ref
R-76619
Required Education
Bachelors Degree
Position Type
Full time
Job Description

The Pivotal Synthetic Drug Product group of the Drug Product Technologies (DPT) department of Amgen at Thousand Oaks, CA is seeking an individual for the position of Principal Scientist. In this leadership role, the Principal Scientist will serve as Drug Product Team Lead (DPLT) providing creative Drug Product development strategies of pivotal and commercial ready programs for innovative synthetic molecules. This Amgen's leader will lead cross-functional and or multi-disciplinary teams and guide junior scientists towards innovative and fast paced development approaches. The individual will 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 leader will interact with external industrial (eg. IQ consortium) and academic groups (eg. University consortia).

Basic Qualifications:

Doctorate degree and 3 years of scientific experience

OR

Master's degree and 6 years of scientfic experience

OR

Bachelor's degree and 8 years of scientific experience

Preferred Qualifications:

Ph.D. in Pharmaceutical Sciences, Material Sciences, Chemistry, Chemical Engineering, or other relevant scientific field with 10+ years of experience in pharmaceutical industry with emphasis, but not limited to oral solid dosage forms

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

Experience in optimization and scale-up studies using QbD principles

Experience interacting with Contract Research/Manufacturing Organizations

Experience as Formulation Development lead serving on interdisciplinary and multidisciplinary teams

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

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

Design, execution and conduction of independent formulation research

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

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.