Job Title: Process Development Scientist – MSAT Analytics
- Bachelor's degree in a biological or biomedical discipline
- Minimum of 2 years' progressive experience with clinical processing analytical testing in the cell therapy industry and/or cell culture operations in the biotechnology industry. The team is looking for people that can hit the ground running.
- Advanced understanding of relevant cell therapy characterization analytical methods, such as flow cytometry, ELISA and qPCR.
- Exposure to one or more advanced potency methods, such as cytotoxicity or cytokine characterization.
- Must have an advanced understanding cGMP and regulations/guidance and can interpret guidance documents and make technical recommendations.
- Experience in analytical transfer, method qualification/validation a plus
- Experience in flow cytometry, (bonus if it's on the MACSquant) and/or PCR (minimally able to hit the ground running on at least one of these method types)
- Advanced understanding of analytical transfer, qualification, and validation.
- The focus of this position is to be the liaison between PD and QC operations, transferring methods from PD to QC as well as providing any additional support to the QC team.
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