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Scientist

Cambridge, MA
Top 3 Must Have Skill Sets:    
  • Experience in process development working in cross-functional teams
  • Excellent analytical/problem-solving skills and perform data analysis
  • Experience with quality systems and writing technical documents

Description:

This position is for a Scientist in the Materials Science group working under the guidance of the hiring manager. The Scientist will support a range of cross-functional activities to support media, chemical and excipient raw materials used for synthetic and biologic processing.

Core job responsibilities include:
  • Representing the Materials Science function as a technical SME within process development in cross-functional teams with supplier quality management and supply chain.
  • Supplier Change Notifications - assessing impact of supplier changes to the raw material attributes and subsequent impact to our processes and product
  • Raw material non-conformances – Root cause investigations, evaluation of supplier SICAR responses and CAPAs
  • Raw material early engagement - Establish target attribute profiles of GMP raw materials to facilitate supplier selection and specification development

Required Qualifications

BS/BA or Masters in engineering or chemistry and at least 2 years of experience working in the biotechnology/pharmaceutical industry

Required Skills and Experience
  • Experience with quality systems and writing regulated documents
  • Experience in process development preferred
  • Excellent communication skills (written and oral)
  • Ability to work in cross-functional teams
  • Good organizational skills
  • Excellent analytical/problem-solving skills
  • Be able to multi-task and function in a dynamic environment
  • Ability to work with technical documents and perform data analysis

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

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