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SR SPECIALIST-GXP - Translational Trials Development and Support Laboratory (TTDSL) - Translational Core Labs (TCL)
DescriptionSUBFUNCTION DEFINITION: Manufactures and tests cell in gene therapy products for internal and external phase I/II clinical trials.Provide supervision; training and mentoring to team members. Development; technology transfer; scale up; manufacturing/processing/ and or testing; Qualifications and validations. Analyze data and assist others. Write deviations; participate in external and internal audits. Customer support.REPRESENTATIVE RESPONSIBILITIESManufacturingPerform or supervise activities, GxP production, process development, technology transfer, scale up, quality control, and high complexity analysis as directed following established SOPs and protocols. Complete accurate and detailed records and al


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