伟 刘

Planning of Corporate & Project Portfolio Management Center for all markets and technical platforms.

Drug Substance & Drug Product Portfolio Management

Head of Production in charge of production, engineering, and tech.

 Responsible for managing workshop managers and group leaders to maximize quality and output with considering the bills, sales demand and production capacity according to the Master Schedule.  Establishes department policy and operations guidelines. Optimizes production flows while maintaining cost controls.  Monitors production orders and schedules. Analyzes production and operating reports and resolves operational, manufacturing, and maintenance problems to ensure minimum costs and to prevent operational delays.  Coordinate Workshop and Quality Control, Quality Assurance to ensure the GMP system under the regulations of CFDA and FDA, specially for the treatment of deviations and change controls.  Coordinate Warehousing Department to guarantee the raw materials or ingredients with the consideration of import and delivery time, especially for organization of rareness and emergency materials.  Carry out 6σ-projects of lean production to improve the technical specification of products. Maintain the location-fixing management as the 5S standard.  Accomplish FDA’s inspection and customer Audit. Complete registration of API for CFDA and FDA.  Work closely with plant personnel in the areas of EH&S. Develops programs within these areas, ensures the plant is in compliance with the EH&S standards and establishes training requirements for all employees.  Collaborate with Equipment Department to set up maintenance schedule of plant and equipments. Monitor the progress, and revise the reports. Optimize the product process and procedures to promote Automation and Intelligence.

 Manage the pilot research activities within the R&D including the coordination of production batches, environmental concerns, and safety issues.  Coordinate production schedules based on registration and/or clinical requirements.  Improve stability of chemical processes based on process data analysis/process modeling. Integrating the process with the analytical controls to ensure the pilot process validation successfully.  Responsible for transferring of new technology from Process Development to Manufacturing. Establish the scaling-up production line and select the appropriate equipments for the Manufacturing Line within the plant.  Responsible for delegating and ensuring completion of personnel management activities, including cGMP training and other regulatory specifications of employees.  Assist in trouble-shooting activities on-site. Apply “Process-Fit-to-Plant” concept.  Communicate with the internal partners, including synthesis development group of R&D, Production Workshop and Equipment Department to drive the commercial products.