Job Description

Major responsibilities

  • Engage in tech transfer business, such as preparation of TTP, gap analysis, knowledge transfer and training, to proceed the project as schedule.
  • Ensure the integrity of tech data and documentations, and timely update as required.
  • Conduct the process related investigation, optimization and scale-up study.
  • Handle the tech related troubleshooting, deviations, change and CAPA during manufacture business.
  • Participate in the related validation studies, including chromatography resin, reusable filter member lifetime validation, mixing study, cleaning study and yield study et al.
  • Attend in GMP audits, regulatory filing as required.

    • Education, Qualifications, Skills and Experience

  • Master’s degree or above on biological or pharmaceutical relevant major. Graduates from 211/985 Project universities and those with overseas work experience are preferred.
  • More than 3 years’ experience in MSAT or pro...

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