Specialist IS Analyst

Location: Cambridge, MA
Date Posted: 03-15-2018
Day to Day Responsibilities:
  • 20%: Develop new and customized spotfire reports
  • 50%: Leverage spotfire and other similar tools for quantitative data (on product quality and analytical method performance) visualization and analysis
  • 30%: Interface with QC, quality assurance, process development to resolve product quality and method performance issues.

The Attribute Sciences Data Engineering group applies scientific and technical engineering expertise in support of Amgen’s pipeline and commercial portfolio. This team applies continuous verification principles and advanced data analytics to advance product and method performance.
This position is part of the ASDE group providing support to Amgen’s commercial portfolio through application of process monitoring, data analysis, and engineering principles. Responsibilities will include identifying abnormal data trends in product and method data, identification of root causes for trends and collaborating cross-functionally to implement corrections. In addition, this role will focus on identifying and deploying optimization opportunities. The position offers the opportunity to engage with multiple product modalities across a global manufacturing network.

Position Responsibilities:
  • Apply statistical trending tools to product and method data
  • Apply engineering principles and multivariate statistical analysis in-order to understand sources of variation and evaluate opportunities for improvements
  • Use data analytics software to develop visualizations to review, assess, and improve analytical method performance
  • Interface with QC, quality assurance, and manufacturing organizations to resolve method issues
  • Support generation of annual product review documents, regulatory inspections, and process documentation

Basic Qualifications
  • Master’s degree (OR)
  • Bachelor’s degree and 2 years of Engineering experience (OR)
  • Associate’s degree and 6 years of Engineering experience (OR)
  • High school diploma / GED and 8 years of Engineering experience

Preferred Qualifications
  • Experience in applying data analysis, database management and statistical analysis, in-order to solve analytical method issues and evaluate opportunities for improvements
  • Familiarity with software tools (Spotfire/R/Matlab, etc.) to aggregate and analyze/visualize data
  • Able to understand and apply statistical process control concepts
  • Possess understanding of regulatory and cGMP requirements
  • Ability to deliver high quality results in a timely manner
  • Excellent written and verbal communication
  • Strong leadership skills and decision making abilities.
  • Demonstrated ability to work under minimal direction.
  • Able to adapt to changing business needs and operational requirements.
  • Familiarity with systems used for data analytics
  • Understanding of data structures, data types, and system thinking concepts
  • Be able to multi-task and function in a dynamic environment
  • Have strong influencing and negotiation skills
  • Ability to solve difficult, non-routine analysis problems, applying advanced analytical methods as needed.
  • Ability to develop a comprehensive understanding of Amgen data structures and metrics

"This posting is for Contingent Worker, not an FTE"
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