Career Category

Job Description

This Sr. Associate Data Scientist is part of the ASDE group providing support to Amgen’s commercial portfolio through application of process monitoring, data engineering, data analysis through statistical and machine learning algorithm, 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 Process Development, Product Quality, Quality Control, Quality Engineering, quality assurance, and manufacturing organizations to resolve method issues
• Support generation of annual product review documents, regulatory inspections, and process documentation
• Stays abreast of new technologies and statistical approaches in order to recommend improvements

Basic Qualifications

• Master’s degree OR
• Bachelor’s degree and 2 years of Engineering or data sciences experience OR
• Associate’s degree and 6 years of Engineering or data sciences experience OR 
• High school diploma / GED and 8 years of Engineering or data sciences experience

Preferred Qualifications

• 1-3 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role
• Experience with engineering principles and statistical analysis
• 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
• Ability to solve difficult, non-routine analysis problems, applying advanced analytical methods as needed
• 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
• Able to multi-task and function in a dynamic environment
• Possesses strong influencing and negotiation skills
• Ability to develop a comprehensive understanding of Amgen data structures and metrics