- 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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