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operation of mechanical systems, monitoring systems, and equipment. Coordinate preventative maintenance and maintain cGMP compliance for building systems and major process equipment. Conduct internal cGMP and
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metabolic alterations in this process. They are also interested in characterizing the role of health disparities on these mechanisms. For more information about Dr. Shuck’s lab, please visit here. As a
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to appropriate committees, ensuring timely completion of the approval process. Keep stakeholders informed of protocol approval and activation issues, including regulatory status updates for sponsors and
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-process and release testing of GMP Manufacturing and analytical development for cellular immunotherapy products. This is a fast-paced lab involved in cutting edge technology, research and clinical cellular
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accurate documentation throughout the research process. Compile and submit data according to protocol guidelines, ensuring compliance with study requirements. Actively recruit patients for studies and assist
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, shaping the future of medicine through cutting-edge research. The QC team for Cellular and Gene Therapy Operations seeks a skilled Quality Control Manager to oversee in-process and release testing for GMP
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negotiation and development, and performing necessary performance management to ensure project success within defined cost parameters. Process development and implementation Designs and develops systems
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in to IRB clinical trials. Assess and document signs and symptoms of illness, reactions to treatment, changes in physical or psychological condition and general appearance in accordance with the IRB
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determinations. Enter and/or review financial data in OnCore and initiate the sign-off process of the OnCore calendar/financial console. Review protocol amendments for any revisions affecting the coverage analysis
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process to ensure compliance with regulations. Conduct pre-reviews of submissions, ensuring completeness and compliance, coordinating timely reviews, preparing committee minutes, and issuing action notices