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发表于 2013-12-21 10:16:44
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Jason Liou is Expert in Pharmaceutical Product Development and Good Manufacturing Practices (cGMP, IQ/OQ, CMC, FDA, CFDA, TFDA, EU, etc.)
Expert is a professional to the pharmaceutical and biotechnology industries. His background includes 20 years with Pfizer and Abbott in a variety of positions. In his last assignment at Pfizer, he was manager in pilot Plant/Manufacturing responsible for introduction of new products (both final dose form and the bulk pharmaceutical chemical). This responsibility included technology, manufacturing business planning, and project management. Other responsibilities included technical troubleshooting for Antiviral API & final dose form at contract plants, chemical manufacturing, and central project engineering.
Expert is knowledgeable and up-to-date in current Good Manufacturing Practices (cGMPs), especially as applied to bulk pharmaceutical chemicals and Sterile process products. As a Quality Director in Kanion Pharmaceuticals , Expert led the assessment of bulk raw materials and drug substance suppliers from cGMP, business, management, environmental, and technology perspectives. Quality management of products included capsules,t ablets, coated and uncoated, injectable drugs made by both aseptic process and terminal sterilization, and lyophilized products. Expert can answer detailed questions concerning pharmaceutical products and product development, and parenteral product processing.
Expert also started-up the chemical development function in Egretpharma (Shanghai) This included initiating cGMPs for a contract facility and new group. As a quality manager at Norvartis (Shanghai), he has made several audits of bulk manufacturers, primarily cGMP related.
As Senior Director of CMC in Egretpharma, Expert was responsible for the pilot product troubleshooting (process and analytical methods) and transfer of new products from R&D to pilot plant/manufacturing. Expert has written and reviewed Chemistry, Manufacturing, and Controls (CMC) sections for INDs, ANDAs, and DMFs covering both bulk drug an d final drug products.
Throughout Expert's industrial career (>24 years), all his positions have been involved in process research and development, manufacturing, technology transfer from development to manufacturing and quality management. All these positions involved interfacing between R&D, and Pilot Plant/manufacturing. His skills have been honed in process and product development, transfer of technology, strategic long range focus in planning and facilities, up-to-date knowledge of pharmaceuticals cGMPs (especially as applies to bulk drugs and injected drug product), and management of contract development and manufacturing firms. |
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