Mira Bailey
Senior Technology Transfer Project Manager @Fresenius Kabi USA
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WORK HISTORY
Senior Technology Transfer Project Manager @Fresenius Kabi USA
Responsible for the transfer and implementation of defined processes for new products to the plant manufacturing site, as well as for implementing manufacturing procedures for new or modified products. Maintain the product life cycle which includes development, stability, process performance qualification.• Lead in preparing the manufacturing site for the manufacture of new products. Evaluate project scope. Prepare and track the project schedule via ongoing communication with the various plant departments, other support departments, project team members, and other internal customers.• Lead the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, and manufacturing of development, stability, and process qualification batches. • Prepare master batch records and protocols for the manufacture of development, stability, and process performance qualification batches. • Work with management to translate development findings into manufacturing processes. Provide information and documentation needed for regulatory submissions.• Provide technical assessment of changes in manufacturing through appropriate review of documentation and testing results. Execute necessary investigative studies to address product deviations and changes to a manufacturing process.
EDUCATION
M.S. Bashkir State University, Ufa, Russia
Master's degree
ABOUT MIRA BAILEY
Program Manager with expertise in technology transfer, Manufacturing Science & …
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