Amgen

Process Development Senior Associate

Employer
Amgen
Location
Rhode Island, RI, US
Posted
Mar 22, 2019
Ref
R-68412
Required Education
Associate Degree
Position Type
Full time
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.