Process Development Associate - Drug Product Technology Department

Job Description

The Synthetics Enabling Technology Group within the Drug Product Technology Department (DPT) of Amgen at Thousand Oaks, CA is seeking an a Associate. SET is a key DPT interface with partners in Process Development, Discovery Research, and Translational Sciences, conducting molecule assessment of synthetics, staging molecules, identifying and executing strategies for discovery and early development. Within this space Synthetics Enabling Technologies:

• Provides synthetics molecule assessment (developability assessment) and preclinical formulation support.

• Enables lead optimization and form selection to meet discovery research and process development requirements (Target Product Profile).

• Utilizes predictive in silico and in vitro models to support molecule and biopharmaceutical assessments to identify development strategies.

• Conducts the solid-state characterization and support DS and DP process development.

• Provides early clinical support for synthetics liquid dosage forms (e.g. drug-in-bottle, parenteral) and conducts technical transfers to support clinical manufacturing (GMP).

This individual will support early structural elucidation of small molecules and their degradation products to support molecule assessment and formulation development.

Basic Qualifications:

Bachelor's degree

OR

Associate degree and 4 years of scientific or research experience

OR

High school diploma / GED and 6 years of scientific or research experience

Preferred Qualifications:

Bachelor's degree and 1+ year of industrial experience in Pharmaceutics, Chemistry or related field.

Experience in utilizing mass spectrometry (e.g. LC-MS) and a strong background in organic or analytical chemistry is highly desired

Experience with preformulation techniques including HPLC, physical-chemical evaluation (solubility, stability, pKa and LogP determination, etc.) and solid-state characterization (DSC, TGA, XRPD, microscopy, moisture sorption, etc.) is beneficial.

Computer competency and experience, particularly with Microsoft Excel and other data analysis software.

Ability to take initiative, work independently, and be flexible in responsibilities is important.

Excellent oral and written communication skills for timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment are strongly desired.

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.