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2023-05-24

Scientist 面议
Department: Pre-Clinical
  • Nanjing|| ||
  • 5-10 years
  • Master
  • Full time
  • 1
Description of position:

Responsibility:

  1. Responsible for physicochemical analysis and characterization of therapeutic antibodies, including methods such as: SE-HPLC, IE-HPLC, CE.
  2. Develop, optimize and validate new analytical methods.
  3. Support drug substance process development including characterization of starting materials, intermediates and final API.
  4. Support drug product formulation and process development including characterization of the process and finished product.
  5. Drug substance and drug product impurity characterization and identification. Analyze the stability issues of drug substance and drug product.
  6. Review analytical data for completeness and correctness.
  7. Report and discuss analytical results and conclusions both orally and in writing.
  8. Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.

Requirements

  1. MS  3+ of years experience in protein chemistry, analytical chemistry or other bioanalytical science-related disciplines.
  2. Comprehensive knowledge of HPLC/CE with research experience in protein characterization. Experience working with therapeutic antibodies is a plus.
  3. Good problem-solving and troubleshooting skills.
  4. Good capabilities in experimental design and execution.
  5. Strong collaborative teamwork and excellent communication skills, is energetic, highly self-motivated and able to work efficiently and productively in a growing company environment.
 InxMed

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