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Process R&D Director of Solid Oral Formulation
2014-08-11 15:21:51
  Position Description:
   Guide and manage the R&D, improvement, technology transfer and validation of process of solid oral formulations.
   Requirement:
   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, reverse engineering 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. Familiar with sustained release and control release solid oral formulations and process development, can choose the reasonable excipients, formula and process base on the physical and chemical characteristics of drug substances.
   5. Have strong understanding of the characteristic of packing materials, can choose the reasonable packing materials base on the characteristic and requirements of solid formulation, can do the packing materials verification.
   6. Familiar with the advanced solid oral 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 EMA) of medicine research, and cGMP regulatory requirements.
   8. Familiar with the principle, performance and quality of solid oral formulations R&D and manufacturing equipments.
   9. 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.
   10. Lead the R&D project team to fulfill the process research and development tasks.
   11. Strong document writing skills and good at using MS software.
   12. Good command of chemical and pharmaceutical English, capable of communicating with foreign customers through listening, speaking, reading and writing.
   13. Oversea studies and working experiences of related industry in foreign countries will be 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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