Job Summary

  • Support CMC Analytical activities for Crispr clinical programs by reviewing batch records, assay results.
  • Perform Data Review for integrity and accuracy and collate data in a highly organized manner
  • Use statistical software to analyze the data for shelf life trending and control chart trending
  • Monitor stability program for time pulling of the samples, scheduling and following the results with the testing labs.
  • This is a Cross-functional and highly visible position within Technical Operations group. The position requires active collaboration with research, process development and quality teams and CDMOs
  • Support assay qualification and validation activities and interact with CMOs and other vendors, as required.
  • Conduct and document OOS and lab investigations and CAPA management
  • Write SOPs, Qualification Protocols and qualification reports
  • Perform additional duties as required.


  • MS with 1-2 years’ experience; BS with 3-4 years of relevant experience in industry,
  • Experience in Data review, organizing the data and data analysis by using statistical software
  • Experience in organizing detailed documentation and reporting to the stakeholders.
  • Possess good GMP and GDP skills and has experience on using Quality systems.
  • Good knowledge of QA compliance skills (auditing, lab investigation)
  • Experience in routine PCR, SDS PAGE and Bioassays
  • Excellent organization skills, able to multi-task in a fast-paced environment with changing priorities. Must be able to work effectively as part of a multi-disciplinary team.
  • Understanding of statistical tools, such as SPSS, JMP, DoE, Prism etc. will be a plus.
  • Track record of completing deliverables within specified timelines and “do-what-it-takes” attitude.
  • Superb communications—both written and oral skills.
  • Independently motivated, detail oriented and good problem-solving ability

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