Job Details

  • Title:
    Scientist
  • Code:
    RCI-AMG-5680
  • Location:
    Cambridge Massachusetts (MA) 02138
  • Posted Date:
    04/15/2019
  • Duration:
    7 Months
  • Status:
    Open
Recruiter Contact Detail

  Job 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 within process development in cross-functional group projects as technical SME working with supplier quality management and supply chain
  • Supplier Change Notifications - assessing the impact of change to product and process
  • Raw material non-conformances – Root cause investigations, evaluation of SICAR Responses (CAPAs) and effectiveness verification of supplier CAPAs
  • Raw material early engagement - Technical SME for raw material sourcing required to establish new GMP raw materials and suppliers
Must Have Skills:
  • Experience with GMP manufacturing, quality systems and writing regulated documents
  • Experience in process development
  • Ability to work with technical documents and perform data analysis
  • Will come from a chemical engineering or chemistry background who has an understanding of materials science, biochemistry, and chemical synthesis
  • Good communication and ability to work well in a team environment are important as well
Required Qualifications
  • BS/BA in engineering or chemistry and at least 5 years of experience working in the biotechnology/pharmaceutical industry OR
  • Masters degree in engineering or chemistry and at least 3 years of experience working in the biotechnology/pharmaceutical industry OR
  • PhD degree in engineering or chemistry and preferably at least 1 year of experience working in the biotechnology/pharmaceutical industry