TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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Senior Specialist, Cell Culture

Department :  TechOps
Working place :  Hangzhou
Recruitment :  1
Nature of work :  Full-time
Working years of :  3 - 6 years
Minimum academic :  Bachelor's degree
Release time :  16 Oct, 2020
Responsibilities
  • Upstream cell culture of the bulk is performed, including but not limited to the following manufacturing activities: media preparation, cell line recovery, shake flask inoculation, WAVE reactor operation, XDR bioreactor operation, and continuous flow centrifuge operation.

  • Preparation before upstream cell culture production of stock solution, process scale-up and clinical batch production is performed in the newly built production workshop.

  • Be responsible for process monitoring, including real-time review of process parameters and process data/trending.

  • Ensure that the production operation of the stock solution complies with quality and safety regulations.

  • Participate in the investigation and change control to ensure that the change is of added value and that the process and equipment are stable after the change.

  • Participate in technological innovation and continuous improvement, active leadership change can improve the accuracy rate, production efficiency and cost reduction.

  • Prepare the relevant documents, such as production batch record, SOP and validation report.

  • Provide audit support.

  • Perform other tasks assigned by the supervisor.

Qualifications
  • Bachelor degree or above in pharmacy, chemical industry, biology, biochemistry and other related specialties, 3-6 years of experience in cell culture-related work;

  • Good English speaking and writing skills;

  • Be familiar with mammalian cell culture, solution preparation, and GMP production;

  • Be familiar with industrial-scale bioreactors and continuous centrifuges;

  • Have Experiences in 6 Sigma and 5S management is preferred;

  • Be familiar with enterprise management systems, such as LabWare LIMS, SAP, TrackWise, PDOCS and EAMS.