職業發展
Analytical Manager
Position: Analytical Manager
Location: Beijing

Job Description:

Lead a CDMO team to do the analytical activities, including formulation support experiment, method development/verification/validation/transfer, specification establishment and API/packaging /finished product release, and stability studies
Provide support to formulation development and clinical trial material manufacturing
Prepare and review related IND and NDA filing documents for China and other territories (CMC documents, analytical methods, method validation report, stability report and specification writing)
Other job assigned.
 
Requirement:
Bachelor degree or higher in Pharmaceutical Science, Drug Analysis, etc.
At least 5-8 years of experience in a research environment within pharmaceutical industry
Solid background in analytical support in entire drug product development cycle, familiar with API, intermediate, finished product specification development per regulatory requirement
Broad experience in analytical test method development, validation and transfer; good at technical trouble shooting and problem solving
Excellent knowledge and experience with local and global regulatory requirements including China, U.S. and ICH    
Good written English for daily work
 
黑龙江p62中奖规则