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CGMP Process Development Specialist
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Full-time
- USC's Keck School of Medicine is seeking a dynamic individual to work on the process development and manufacturing of cell and gene therapies and other biological products for internal/external users in the university's current Good Manufacturing Practices (cGMP) facility.
- The Process Development Specialist is responsible for developing procedures and methods to produce multiple cell and gene therapy products, identifying equipment and components necessary for cGMP production, implementing necessary changes to the process and reagents for cGMP compliance, executing technology transfer activates, identities, and supports the development of assays for product characterization.
- Responsible for leading process development, optimization, and scale-up activities for the manufacture of cell therapies and biologics.
- Establishes and executes development project plans (e.g., process and assay development, assay qualification, support tech transfer of processes) from cGMP manufacturing and assays to quality control.
- Provides training support to the manufacturing and quality control teams during tech transfer.
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