Amgen

Process Development Engineer

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Apr 04, 2019
Ref
R-74044
Required Education
Masters Degree/MBA
Position Type
Full time
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 automated and manufacturing technologies. The Engineer will play a key role in developing and implementing new capabilities as well as building advanced data analytics tools for streamlining and accelerating analysis and decision making. We are seeking highly motivated candidates to join the Drug Product Technologies team at Amgen's headquarters in Thousand Oaks, CA.

Responsibilities will include:

• Design and conduct studies to develop and implement state-of-the-art automated systems and technologies, which will be applied to support advancements in Drug Product formulation and process development and to drive greater streamlining of existing workstreams.

• Apply digital tools and techniques to automate data structuring, integration with electronic notebooks and analysis of large and diverse datasets.

• Build clear, intuitive visualization tools (e.g. dashboards, charts, reports, apps) to streamline data analysis and enable actionable decision-making.

• Curate data and apply advanced data analytics (e.g. machine learning) to leverage automated capabilities and historical data in deriving novel insights.

• Apply scientific and engineering principles to develop solutions, troubleshoot and interpret data from automated, high throughput, process, and analytical technologies.

• Enable seamless integration of new technologies and analysis tools into work packages through a user-focused design and development approach.

• Identify opportunities and participate in initiatives to increase the speed and quality of study execution, data analysis and visualization.

• 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 protocols, technical reports, regulatory documents, etc.

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

• Coordinate effectively with process teams, IS, Lab Operations, Asset Management, Facilities and vendors to manage workflows and instruments.

The Engineer will operate in a fast-paced, matrixed environment and collaborate successfully cross-functionally to develop solutions to technical challenges in support of large and small molecule modalities across the Amgen network.

The Engineer will need to stay current on the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs.

Basic Qualifications:

Master's Degree

OR

Bachelor's Degree and 2 years of Scientific, Engineering and/or Operations experience

OR

Associate's degree and 6 years of Scientific, Engineering and/or Operations experience

OR

High school diploma/GED and 8 years of Scientific, Engineering and/or Operations experience

Preferred Qualifications:

• Degree in Engineering, Materials Science, Pharmaceutics, Computer Science, Data Science, Bioinformatics, Applied Mathematics, or related discipline.

• Experience in automation and high throughput screening

• Familiarity with pharmaceutical/biotechnology process development

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

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

• Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)

• Self motivation, adaptability and a positive attitude

• Critical thinking, problem solving and independent research skills

• Good organizational skills with strong attention to detail

• Strong project management skills including the ability to manage and prioritize one's project resources (material, manpower, time, etc.)

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

• Excellent communication (oral and written)

• Ability to elevate relevant issues to project lead and line-management

• Ability to work independently and as part of a team with internal and external partners

• Ability to participate in cross-functional teams and work effectively in a fast-paced, highly matrixed team environment

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.