| Position Description：
Guide and manage the development, improvement, technology transfer and validation of process of polypeptide sustained release formulations.
1. Bachelor or master degree in pharmacy, organic chemistry or pharmaceutical chemistry and relevant major, with more than 6 years experience in process R&D, or; PhD degree with more than 4 years experience in process R&D.
2. Extensive knowledge and experience of pharmaceutical formula, familiar with the characteristic of polypeptide products and have success experience in developing polypeptide formulations. Be capable of designing new reasonable polypeptide formulation and solving the technical problems during R&D procedure.
3. Proficient in understanding characteristic and function of different exipient, choose the proper and effective percipients to ensure the success of the formula and process.
4. Understanding of advanced polypeptide formula, especially polypeptide sustained release formulation and familiar with its manufacturing process.
5. Familiar with the advanced research and development process and means, such as DOE, QbD, risk analysis and risk control, process scale-up, change control, technical transfer, validation etc.
6. Familiar with international guidance (including ICH, FDA and EMA) of medicine research, and cGMP regulatory requirements.
7. Familiar with the principles, performances and qualities of R&D and production equipments.
8. Abundant experience in management and leadership, and good ability of communication and negotiation, strong sense of responsibility, provide the R&D personnel with guidance and training.
9. Lead the R&D project team to fulfill the process research and development tasks.
10. Strong document writing skills, proficient use of MS Office software.
11. Good command of chemical and pharmaceutical English, capable of communicating with foreign customers through listening, speaking, reading and writing.
12. Oversea studies and working experiences of related industry in foreign countries will be preferred.