Masters degree in Chemical Engineering, Biology, Biotechnology or related field and completion of a universitylevel course, research project, internship, thesis, or one year of experience involving the following Performing root cause analysis and supporting corrective and preventative action identification for deviations; Applying a fundamental understanding of upstream cell culture unit operations to support commercial manufacturing processes; Performing technical review of process or equipment data; Owning and authoring technical GMP documentation, such as protocols, assessments, or reports; Providing technical review of manufacturing procedures and electronic batch records for drug substance manufacturing execution; Conducting statistical data analysis using software applications, such as JMP, and designing experiments.

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