Synthesis Manager
Responsibility
• Responsible for API synthesis route design, process development, condition optimization and amplification, technology transfer and handover with the production department;
• Demonstrate the R&D product process route or process; Evaluate the safety and stability of the product process, product quality risk, R&D and product cost, and put forward suggestions for improvement;
• According to the R&D objectives, coordinate internal and external resources, timely solve various problems in the implementation process, and ensure that the R&D project is completed on schedule;
• Guide and coordinate the completion of technology transfer, process validation and other work, and provide technical support for problems in the production process;
• Guide and review the writing of project research and development reports and application materials, and cooperate with relevant project applications;
• Daily department management to build a high-quality talent team.
Qualification
• Master degree or above, organic synthesis, pharmaceutical chemistry, pharmaceutical engineering, chemical engineering and related majors are preferred;
• More than 5 years of experience in API synthesis process development, with rich experience in API synthesis amplification and project management;
• Have good team management ability, communication and coordination ability, organizational ability, and strong resistance to pressure;
• Be familiar with the Drug Administration Law, the Good Manufacturing Practice, cGMP, ICH and other European and American and Chinese medical laws and regulations.