• Perform microbial test: method development, method validation and test of drug substances,product, raw materials.
  
• Monitor GMP clean area periodically according to the requirement of SOP.
  
• Perform sample analysis including but not limited to GMP drug substances and products used forclinical trials.
  
• Manage the working organisms and the microbial lab cleaning.
  
• Assume responsibility for assigned instruments, maintaining them in proper calibration andworking status according to the appropriate SOP; Perform IQ/OQ/PQ/PC as assigned.
  
• Write up IQ/OQ/PQ/PC protocols and/or protocol, method or report related to microbial testing.
  
• All work will be conducted in compliance with cGMP/GLP regulations when applicable.
  
• Be expected to perform the job independently with limited supervision from senior scientists,group leaders and senior management.
  
• Must be customer-oriented and able to show flexibility and ability to work with multiple projects.Must be able to prioritize the workload to meet the pre-determined timelines.
  
• Individuals will be expected to accomplish their work assignments by interacting closely withfellow scientists and by developing cooperative working relationships with other personnel insidethe company.
  
• Good communication, open exchange of information and project teamwork will be required inorder to meet job performance. There must be strong recognition of high performance standardsand of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.
  

• Must have experience in microbial test and familiar with biological safety practice.
  
• Must be trained in or be familiar with the requirements of the FDA cGMP/GLP regulations, ICHguidelines as well as drug development process.
  
• BS, MS or Ph.D. degree in microbiology or other directly-related science discipline withexperience or training in pharmaceutical analysis.
  
• Must be experienced with standard analytical techniques, particularly incubator, colony counter,autoclave, Biotest RCS Air sampler etc.
  
• Strong communication skills, both written and verbal, and outstanding interpersonal skills areessential job requirements.
  
• Must be able to work in a team-oriented manner in order to accomplish performance objectives.
  

LOCATION

WuXi City, Jiangsu Province

CONTACT

Please send your resume to: xiao_rui0501@wuxiapptec.com