Process Development Scientist

Rhode Island, RI, US
Mar 22, 2019
Required Education
Position Type
Full time
The Process Development Scientist 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 expert.
  • 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:
  • Doctorate degree
  • OR
  • Master's degree and 4 years of Scientific experience
  • OR
  • Bachelor's degree and 6 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 using HPLC, CE, LC/MS, ELISA, and/or other techniques.
  • Understanding of biopharmaceutical manufacturing processes.
  • Familiarity with forensics investigations and analysis.
  • Demonstrated leadership, either as team lead and/or manager.
  • 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.

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.