CMC Director

Responsibility

• Formulate appropriate development strategies for each stage of CMC of small molecule or PDC (Peptide Drug Conjugate) innovative drug projects, and formulate CMC project objectives；

• Lead the research and development team to complete the process method research and development of the company's small molecule or PDC innovative drug projects, optimize the process technology scheme, manage the development, validation, transfer and other quality work of analytical methods of innovative drug projects, and solve relevant technical problems；

• Organize the preparation and review of Sino US IND/NDA related materials in accordance with relevant domestic and international requirements of CMC for innovative drug research and development；

• Formulate and plan the content, schedule and time node of the company's project process R&D, and improve the project management system；

• Be responsible for closely cooperating with all parties, supervising the compliance of production partners, and monitoring the whole process and implementation of CMC research.

Qualification

• It is required to have a master's degree or above in pharmaceutical chemistry, chemistry and organic synthesis related majors, and a doctor's degree is preferred；

• More than 5 years of innovative drug CMC research and development experience and management experience, with rich practical work experience in drug synthesis, preparation, analysis and research and development；

• Be familiar with the process and regulations of drug registration and R&D at home and abroad; Familiar with QbD, ICH, patent challenge and other fields; Master relevant professional skills and have successful experience in R&D of multiple projects；

• Have strong communication, leadership and management abilities, as well as excellent professionalism and teamwork spirit.