Mark Tsai
Associate Director, Combination Product Development at Otsuka Pharmaceutical Companies U.S
Based in Irvine, United States
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Seniority
Director
Department
Engineering
Location
Irvine
Industry
Pharmaceutical Manufacturing
Company size
3.6K
Contact information
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m•••••••@otsuka-us.com
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Background
About Mark Tsai
With over 20 plus years of combination products and surgical device experience, I offer device development in biopharmaceutical and medical device industries. Competencies * New Product Development and Technical Program Management: Product Concept to Commercialization * Drug Products: Cell Suspensions, Monoclonal Antibodies, Drug Suspensions, Silicone Oil for Ophthalmic Injection * Drug Delivery Platforms: intrathecal drug port/catheter system, Autoinjectors, Prefilled Syringes and subretinal microfluidic drug delivery * Device Industry: intrathecal, ophthalmic, cardiovascular surgical devices and cell-based drug delivery system * Device Types: single-use and reusable devices, implantables, combination products, Class II and devices * Risk Management Process per EN ISO 14971 * Design Control (Design Input, Output, Design V&V, Transfer)* Human Factors Studies * Clinical Plan (Class II and Devices)* Clinical Evaluation (CER) Management
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