Process Development Associate - Pivotal Drug Product

Employer
Amgen
Location
Cambridge, Massachusetts
Posted
Sep 27, 2018
Ref
R-63782
Required Education
Bachelors Degree
Position Type
Full time

Based in Cambridge, MA, the role of Process Development Associate in Pivotal Drug Product Technologies will be to provide support for Amgen's biologics drug product and process design, commercialization and lifecycle management. The Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. In addition to performing process characterization and formulation studies, this role will also focus on data analytics, statistical modeling, and data visualization technologies. The Associate will integrate and utilize platform capabilities, prior product knowledge, and data analytics/visualization to advance Amgen products and ensure success through the commercialization process.

Responsibilities include:

  • Participate in the planning, design, execution, and documentation of studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics
  • Perform analytical characterization supporting attribute and stability assessments using chromatography and biophysical characterization tools
  • Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
  • Create visualizations to enable business application of data analysis
  • Explore and evaluate new digital tools and techniques to improve the team's developmental and operational capabilities
  • As needed, provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
  • Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs

Basic Qualifications

Bachelor's degree

OR

Associate degree and 4 years of scientific experience

OR

High school diploma / GED and 6 years of scientific experience

Preferred Qualifications

  • Bachelor's degree in Chemical Engineering, Biomedical Engineering, Chemistry, Biochemistry, or other relevant sciences
  • Demonstrated ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment
  • Basic understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality
  • Proficiency in at least one statistical software package (such as SIMCA or JMP)
  • Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function
  • Strong problem solving and effective cross-functional communication skills
  • Demonstrated success working with diverse team members in a dynamic, cross-functional environment