Senior Director, CMC Regulatory
KBI is a leading biopharmaceutical contract services company providing fully integrated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally. To date, KBI has helped to advance drug development programs for over 200 clients around the world. KBI offers an extensive suite of expert development and manufacturing services through an agile, science-based and customer-focused approach.
Experienced Scientist Manager with ‘Big-Picture’ understanding and experience bridging clinical and commercial biomanufacturing, contract biomanufacturing, Product Quality Management, Quality Systems & Compliance.Specialties: Development, Validation and Technology Transfer of Analytical and Bioanalytical Methods. Support of Process Development, Product Characterization, Release and Stability testing, Specification Development and Management for Biologics Manufacture. Technical and Compliance Investigations, Problem solving and decision making in cross-functional team settings.
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