3 years of experience in the development, qualification, and transfer of analytical assays for critical starting material and related inprocess impurity in cell and gene therapy, including viralvectors, Cas9, sgRNAs and gene edited cells.br 3 years of experience in assay development and qualification per regulatory guidance USP, ICH, FDA, EMA.br 3 years of experience in drafting documentation and executing GMP testing to support regulatory filings.br 3 years of experience in performing chromatography instrument maintenance and troubleshooting routinely.
Categories: eb3
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