Process Development Senior Scientist

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses in areas of high unmet medical need by discovering, developing, manufacturing and delivering innovative human therapeutics.

Amgen has built a state-of-the-art Process Development facility focused on advancing next generation automation and manufacturing technologies. The Senior Scientist will play a key role in developing and implementing new capabilities to bring high-quality products to patients through excellence in process engineering, development and manufacturing support. We are seeking highly motivated candidates to join the Drug Product Technologies team at Amgen's headquarters in Thousand Oaks, CA.

The responsibilities of this candidate will include:

• Lead the development and implementation of state-of-the-art automated systems and technologies, which will be applied to support advancements in Drug Product formulation and process development.

• Lead key initiatives, develop business cases and build strategies focused on continuous innovation and on the increased speed and efficiency of development activities and data analysis.

• Apply critical thinking and scientific/engineering principles (e.g. chemistry, fluid dynamics, statistics, modeling, etc.) to experimental design, data analysis, system and process development, and complex troubleshooting.

• Lead data science efforts to streamline dataflow, automate analysis and advance data visualization tools to rapidly derive insights and enable effective decision-making.

• Enable seamless integration of new technologies and processes into existing workstreams through a user-focused design and development approach.

• Partner with process teams to ensure clinical and commercial pipeline deliverables are met on schedule and at a high quality.

• Author/review technical documents: technical assessments, technical protocols, regulatory documents, publications, etc.

• Effectively and consistently communicate with management, cross-functional partners and relevant stakeholders on progress towards milestones, risks and strategies forward.

• Interface directly with vendors to drive 'right first time' solutions and improve reliability and performance of automated instrumentation.

• Partner effectively with process teams, Lab Operations, Asset Management, Facilities and vendors to manage workflows and instrumentation.

The Senior Scientist will operate in a fast-paced, matrixed environment and collaborate successfully cross-functionally to implement technologies and processes and overcome technical challenges in support of large and small molecule modalities across the Amgen network.

The Senior Scientist will stay ahead of the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs.

Basic Qualifications:

Doctorate Degree and 2 years of Engineering and/or Operations experience

OR

Master's Degree and 5 years of Engineering and/or Operations experience

OR

Bachelor's Degree and 7 years of Engineering and/or Operations experience

Preferred Qualifications:

• Doctorate Degree in Chemical Engineering, Biochemical Engineering, Chemistry, Pharmaceutics, Mechanical Engineering or related discipline and 5+ years of relevant experience

• Experience in automation and high throughput screening

• Experience with advanced data analytics and modeling methods particularly in their application to process systems

• Statistics and programming background with experience delivering on data science and machine learning projects

• Familiarity with biotechnology/pharmaceutical process development, Drug Product process development and GMP systems

• Experience authoring CMC regulatory sections and the associated requirements

• Experience in team leadership and formulating business strategies

• Strong project management skills and clear-sighted decision-making based on business priorities/strategy/direction, technical considerations and resources

• Strong critical thinking and problem solving abilities

• Good organizational skills with strong attention to detail

• Self motivation, adaptability and a positive attitude

• Excellent communication (oral and written)

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.