Process Development Senior Associate Scientist

West Greenwich, RI, US
Feb 11, 2019
Required Education
Masters Degree/MBA
Position Type
Full time
Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that these molecules become medicines. Many of the technologies we're employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping oncology patients.

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

  • 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 as analytical subject matter
  • Interpret results, author and review technical reports and sections of regulatory filings.
  • 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 and 3 years of Scientific experience
  • OR
  • Bachelor's degree and 5 years of Scientific experience

Preferred Qualifications:
  • Scientist with 5+ years of experience in providing and driving analytical deliverables for biopharmaceutical processes and product development
  • Deep understanding of product quality attributes 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
  • Possess strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements
  • Demonstrated experience working in matrix environment
  • Experience in data analysis, statistical analysis, setting acceptance criteria, comparability studies, and process/method transfers
  • Experience in applying troubleshooting and investigation methodologies for problem solving. This includes technical support for nonconformance investigations and other commercial support activities.
  • Strong technical writing, verbal communication and presentation skills

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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

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.