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Process Development Senior Associate

Employer
Amgen
Location
West Greenwich, RI, US
Start date
Feb 11, 2019

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Job Details

As a Process Development Senior Associate, this role will be a member of the Commercial Attribute Sciences group in Amgen Rhode Island.

Responsibilities:
  • Execute routine and characterization testing using multiple analytical methods and technologies to support commercial and NPI programs.
  • Interact and collaborate with other functional areas in matrix environment.
  • Interpret results, author and review technical reports and assessments.
  • Support process and method lifecyle management, including testing to support process improvements, Comparability, small-scale models and method transfers, qualifications, and remediations.
  • Support site Forensics team in commercial manufacturing and PD investigations.


Basic Qualifications:
  • Master's degree
  • OR
  • Bachelor's degree and 2 years of Scientific or Operations experience


Preferred Qualifications:
  • Scientist with 2+ years of experience in providing and driving analytical deliverables for biopharmaceutical processes and product development.
  • Deep understanding of product quality attributes for biologics, their control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product.
  • Expert knowledge of analytical methods/technologies used in biologics for both routine and characterization testing using HPLC, CE, ELISA, and/or other techniques.
  • Familiarity with biopharmaceutical manufacturing processes.
  • Familiarity with forensics analysis.
  • Familiarity with regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.
  • Experience working in a matrix environment.
  • Experience in data analysis, statistical analysis, method qualifications/transfers.
  • Experience in applying troubleshooting and investigation methodologies for problem solving.
  • Strong technical writing, verbal communication and presentation 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.

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.

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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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