• Plan and execute method development and validation for drug substance.
  
• Perform sample analyses including but not limited to samples for drug substance used forclinical trials and GMP drug substance to be released.
  
• Execute stability program for drug substance under cGMP where applicable.
  
• Characterize the primary and secondary reference standards for lab use within the companyand analytical development clients.
  
• Assume responsibility for assigned instruments, maintaining them in proper calibration andworking order according to the appropriate SOP.
  
• Write up formal analytical methods, method validation reports, stability study summary,Certificate of Analysis (CoA), method validation protocols and/or summaries/reports relatedto analytical research and development works.
  
• All work will be conducted in compliance with cGMP 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 multipleprojects. 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
  
• with fellow PDS scientists and by developing cooperative working relationships with otherpersonnel inside the company.
  
• Good communication, open exchange of information and project teamwork will be requiredin order to meet job performance. There must be strong recognition of high performancestandards and 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 analytical method development and validation as well as
  
• pharmaceutical analysis according to written method/protocols.
  
• Must be trained in or be familiar with the requirements of the FDA cGMP regulations, ICHguidelines as well as drug development process.
  
• BD and above degree in analytical chemistry, pharmaceutical analysis or other directlyrelatedscience discipline with experience or training in pharmaceutical analysis.
  
• Must be experienced with standard analytical techniques, particularly HPLC, GC. GC-MSLC-MS experience/familiarity with dissolution apparatus is desirable.
  
• 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 performanceobjectives.
  

LOCATION

WuXi City, Jiangsu Province

CONTACT

Please send your resume to: xiao_rui0501@wuxiapptec.com