Michael Jen-Yi Lee Email & Phone Number

Manufacturing Division Director with a demonstrated history of working in the pharmaceutical industry and project management. Skilled in Pharmaceutics, GMP, GCP, ICH-CTD, and Regulations.Professional Experience:● Conduct new drug, new formulation new drug and generic drug development project and lead R&D and RA staff to achieve the regulations needs and obtained more than 10 drugs approvals by FDA.● Work with New Drug Development Team and Product Managers to understand their goals and objectives and provide solutions and risk assessment that meet their needs.● Management/Coordination liaison for two ODM new drug projects with formulation development, manufacture processing establishment, stability assessment, and delivered CTD Module 3 dossier to assist client to complete USFDA and TFDA IND application and conduct phase II clinical trial in Taiwan.● Lead the R&D and RA team to develop health/nutritional supplements projects and launched more than 30 products to the market.● Coordination R&D, RA, MIS and external consultants for establishing Product Life Management (PLM) software in pharmaceutical product development. Eventually, we linked the project schedule estimate and project activity deliverables to the CTD Module 3 dossier. It can help us to monitor and control time and save budget in a project.● Lead the Serialization Project to coordinate RA, TS, PD and external consulting team to establish the medicinal product Track & Trace system. We have successfully completed the serialization system implantation in 7 months and delivered the product to our client oversea.