Career Category

Job Description

Amgen is currently seeking a Senior Scientist for our Pre-Pivotal Drug Product Technologies Group focusing on biologics therapeutic formulation and process development in Thousand Oaks, CA. The Senior Scientist will provide technical leadership and be responsible for conducting experiments to characterize bispecific protein modalities as well as monoclonal antibodies and other proteins. The candidate will be expected to drive advancement of biologics therapeutic development through technological innovation and application of high throughput and automation to experiments that include formulation screening, stability studies, and biophysical characterization.

Responsibilities will include:

• Support early phase process development of protein therapeutics
• Support the application and advancement of High Throughput and Automation Technologies to protein therapeutic sample preparation and characterization.
• Active participation and representation of drug product process development group in cross-functional project teams across organization
• Formulation screening and development for a range of protein modalities.
• Responsible for planning, design, execution of stability studies, process development and design, in use compatibility studies, FIH formulation studies and authoring CTA/IND filings 
• Leading the implementation of workflows to enhance data processing, archival, and presentation efficiencies.
• Continuous adherence to compliance and legal requirements while meeting organization’s goals and priorities
• Identify and optimize unit operations to improve process robustness, throughput, and cycle time

Additional responsibilities will include detailing and retrieving scientific results in electronic notebooks, authoring and reviewing regulatory filings, participating in group and project meetings, and presenting at departmental seminars. The candidate will deliver progress reports, presentations, publications, and patent applications as appropriate. The candidate is expected to work positively and collaboratively to influence and inspire colleagues from discovery and development organizations.

Basic Qualifications:

• Doctorate degree and 2 years of scientific experience OR
• Master’s degree and 5 years of scientific experience OR
• Bachelor’s degree and 7 years scientific experience

Preferred Qualifications:

• Doctorate in Molecular Medicine, Biotechnology, Pharmaceutical Sciences, Biochemistry or other relevant sciences with 2+ years of industry experience
• Experience with formulation and stability of proteins.
• Experience with analytical characterization of protein degradation
• Knowledge and experience with biophysical characterization of proteins.
• Experience with high throughput and automation technology and its application to protein therapeutic development.
• Experience with data science applications for the development and optimization of digital workflows.
• Proven track record problem solving and trouble shooting in biotherapeutics discovery/development environment; Demonstrated ability to independently identify, develop and implement scientific solutions to practical problems
• Track record of innovation; Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications and patents
• Motivated self-starter with excellent interpersonal and organizational skills; Excellent verbal communication and scientific writing skills
• Leadership experience of progressively increased scope and a demonstrated ability to inspire and lead a group of scientists to deliver on complex and challenging objectives in defined timelines would be strong plus
• Demonstrated success working with diverse team members in a dynamic, cross-functional environments and ability to learn and act at a rapid pace
• Project leadership, strong problem solving and effective cross-functional communication skills with sense of urgency and passion