Process R&D Specialist (associate director) of Peptides

2015-07-24 16:41      
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 formulations and solving the technical problems during typical R&D processes. 
3. Proficient in understanding the characteristics and functions of different excipients, and choose the proper and effective excipients 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 EMEA) of medicine research, and CGMP regulatory requirements.
7. Familiar with the principles, performance and qualities of typical R&D and production equipment.
8. Abundant experience in management and leadership, with good ability to communicate and negotiate, and a strong sense of responsibility to provide supervised R&D personnel with guidance and training.
9. Lead the R&D project team to fulfill process research and development tasks.
10. Strong document writing skills, and proficient use of Microsoft Office software.
11. Good command of chemical and pharmaceutical English, capable of communicating with foreign customers through listening, speaking, reading and writing.
12. Overseas studies and work experience in the pharmaceutical industry in foreign countries is preferred.
*Annual salary for the positions above is 80,000-120,000 dollars, but for special talent, it will be discussed separately.

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