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PROCESS DEVELOPMENT SCIENTIST

Employer
Amgen
Location
Thousand Oaks, CA, US
Start date
Oct 8, 2019

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Job Details

The Process Development Scientist is part of Cleaning Characterization group based in Amgen's Thousand Oaks, CA corporate headquarters, who are responsible for the development of cleaning process design supporting new product introduction in Amgen internal and external manufacturing network for both drug substance and drug product. The cleaning characterization group develops new processes including chemistries, temperature and contact time that support the implementation of cleaning validation studies within Amgen manufacturing sites. The group supports investigation of deviations/non conformances, writes technical cleaning evaluation reports, and supports plant inspections, including Prior Approval Inspections (PAIs).

Job Responsibilities
  • Design and perform planned experiments for developing large-scale processes
  • Help develop new methods, apparatus and procedures for bench-scale characterization work and scale-up
  • Write technical reports, assessments, and procedures
  • Use characterization data to develop key operating parameters (KOPs), testing requirements and acceptance criteria for new product launches
  • Work with Quality, Engineering and Process Development to implement Validation requirements at full scale
  • Help write technical papers for internal and external publication


Basic Qualifications

Doctorate degree
OR
Master's degree and 4 years of Scientific experience
OR
Bachelor's degree and 6 years of Scientific experience

Preferred Qualifications
  • Chemical Engineering Background with validation and laboratory studies experience.
  • Design and execution of bench-scale experiments
  • Analytical methods: Total Organic Carbon (TOC), protein assays, gel electrophoresis, spectroscopic methods
  • Characterization and validation of processes for biologicals
  • Good knowledge of scientific principles, methodologies and practices
  • Lab methods, including handling and dispensing chemicals, preparing buffers and operation of common lab equipment, such as pH and conductivity meters
  • Strong interpersonal skills
  • Good written and verbal communication skills


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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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