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Director of Manufacturing Sciences And Technology
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- 3) Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems
- 4) Co-own the site tech transfer process and SOP with R&D
- 5) Charter cross-functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations
- 6) Work with the site leadership team to build subject matter expertise across functions in the areas of compounding, sterilization, and single-use assemblies for filtration and filling, device assembly, and visual inspection
- 7) Be accountable for site process control strategy document, technical transfer change controls and protocols and ensure that the manufacturing batch record meets established conditions as defined in the CMC documentation
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