Process R&D Director of Solid Oral Dose Formulation

2015-07-24 16:40      
Guide and manage the R&D, improvement, technology transfer and validation of process of solid oral dose 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 solid oral formulations (tablet, capsule, particulate and sustained release formulation), familiar with the characteristic of different kinds of solid oral formulations and have success experience in developing different formulas of solid oral formulation. Be Capable of designing new formula, reversing engineering and solving the technical problems during typical R&D processes.
3. Proficient in understanding the characteristics and functions of different exipients, and choose the proper and effective excipients to ensure the success of the formula and process.
4. Familiar with sustained release and control release solid oral dose formulations and process development, able to choose the reasonable excipients, formula and process basing on the physical and chemical characteristics of drug substances.
5. Having strong understanding of the characteristics of packing materials, able to choose the reasonable packing materials basing on the characteristics and requirements of solid dose formulation as well as to do the packing materials verification.
6. Familiar with the advanced solid oral dose formulation research and development process and means, such as DOE, QbD, risk analysis and risk control, process scale-up, change control, technical transfer, validation, etc.
7. Familiar with international guidance (including ICH, FDA and EMEA) of medicine research, and CGMP regulatory requirements.
8. Familiar with the principles, performance and qualities of solid oral dose formulations R&D and production equipment.
9. 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.
10. Lead the R&D project team to fulfill process research and development tasks.
11. Strong document writing skills, and proficient use if Microsoft software.
12. Good command of chemical and pharmaceutical English, capable of communicating with foreign customers through listening, speaking, reading and writing.
13. 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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