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bluebird bio offers products based on the transformative potential of gene therapy for patients with genetic and orphan diseases.
A business leader with more than sixteen years of experience in manufacturing of biologics and vaccines with leadership in Manufacturing, Quality, Tech Transfer, Validation, and Technical Services organizations. Experience includes aseptic manufacturing, large capital projects, quality systems, process troubleshooting/optimization, technology transfer, and a wide range of regulatory activities (including numerous new facility filings and regulatory inspections). Specialties: Strong history of sponsoring regulatory compliance and interacting directly with agencies around the world, including FDA (CDER and CBER), EMA, TGA, MHRA, WHO, BGTD, ANVISA, Korean FDA, and the Ministries of Health for Mexico, and Argentina Certified Lean Six Sigma Black Belt
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