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Biologics FFF E&L Senior Scientist(Shanghai , China)

Key Accountibilities:

  • Optimize platform to provide Extractables/Leachables evaluation and trace level analytical support for parenteral product development programs.
  • Develop and validate E&L analytical methods (GC/MS, LC/MS, HPLC, FT-IR, ICP-MS and etc.) with minimal supervision.
  • Conduct routine analytical testing.
  • Provide leadership for various operational tasks within laboratory including use and maintenance of modern analytical instrumentation such as GC/MS, LC/MS, HPLC, FT-IR, ICP-MS and etc.
  • Possess good judgment and awareness to recognize and solve laboratory/data issues to assure high quality data.
  • Write validation protocols, validation reports, technical reports, investigations, and documents for regulatory submissions.
  • Other duties as assigned
  • Requirements:

  • Ph.D degree in analytical chemistry, Pharmacy, biochemistry, or related science areas with at least 2 years of relevant experience.
  • Analytical problem-solving skills, utilizing and maintaining modern analytical instrumentation such as GC/MS, LC/MS, HPLC, FT-IR and etc.
  • Chromatographic method development and validation experience.
  • Lab experience including research in GMP environment is desirable.
  • Must be self-motivated, possess good interpersonal skills, and the ability to handle a wide variety of work assignments while meeting tight timelines.
  • Excellent communication skills, including technical writing and oral communication in both Chinese and English;
  • Computer skills (Excel, Word, PowerPoint, Minitab), Experience with Empower and ChemStation chromatographic data systems