招大分子蛋白分析方法开发副总监

张春晖

General Job Accountability

The Associate Director (AMD) is a managerial position responsible of providing leadership to and managing the daily operations of the AMD group. You will be in charge of the analytical method developments, product characterization, and to provide supports for process design/characterization. The position is also responsible to provide analytical supports to company’s regulatory filings, in particular IND and BLA filings.

Job Description

• Lead analytical method developments in monoclonal antibody product development programs;
  
• Transfer of analytical methods to other functional groups for in-process and/or drug substance (DS)/drug product (DP) release supports;
  
• Plan and execute necessary characterization of monoclonal antibody to support IND and BLA filings. These include structural and degradation pathway characterizations, as well as resolving stability issues and to support formulation development;
  
• Evaluate and implement new analytical technologies;
  
• Collaborate and coordinate with colleagues from basic research, product development, process development, manufacturing, QA and QC teams to increase product quality.
  
  

Job Requirements

Education /Training background:

• MS with 5-10 years’ relevant experience or PhD with 4-8 years’ relevant experience;
  
• Degree in analytical chemistry, biochemistry, biophysics, pharmaceutical chemistry or related field.
  
  

Knowledge/Skills:

• Must have experience in analytical/process development with hands-on and in-depth understanding of different protein characterization techniques and associated instrumentation such as HPLC/UPLC (RPC, SEC, IEX), Capillary Electrophoresis, GC, LS/MS etc. Additional hands-on experience and understanding of protein purification is preferred.
  
• Good understanding of cGMP, pharmacopeia testing and regulatory requirements for filing and registration of biologics is highly desirable;
  
• Excellent communication skills: Fluent in Chinese (speaking and writing) and English (reading and writing) to present the company well in internal and external meetings.
  
• Excellent personal skills to work with diverse team members across various functions, multiple countries at various levels in organization.
  
• Must be self-motivated and be able to work with minimal supervision in a matrix environment and effectively manage multiple projects.
  
• Must be capable of multiple-tasking with demonstrated good initiative and judgments.
  

Location in Shanghai
Please send message to zhang9027@sina.com, if you have interest or question.