TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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Specialist, QC Activity

Department :  TechOps
Working place :  Hangzhou
Recruitment :  1
Nature of work :  Full-time
Working years of :  More than 1 years
Minimum academic :  Bachelor's degree and above
Release time :  16 Oct, 2020
Responsibilities
  • Be responsible for the daily detection of biological activity, protein A residue and host cell protein residue of laboratory samples, and ensure the timely and effective completion;

  • Solve technical problems in the application of analytical methods;

  • Report the deviations and OOS occurred in the experimental test, participate in the investigation and the implementation of CAPA;

  • Be familiar with GMP regulations, organize the writing of SOP, validation protocol and validation report of analytical methods;

  • Be responsible for the maintenance of laboratory instruments and meters,and the drafting and review of relevant SOPs. If necessary, be responsible for the 3Q verification of laboratory-related equipment;

  • Participate in the activity analysis of product stability research and write stability research reports;

  • Participate in the compliance management of the active analysis group;

  • Actively complete other work tasks delivered.

Qualifications
  • Identify the corporate culture of the company and be enterprising and responsible for the job;

  • Bachelor degree or above, major in biochemistry, drug analysis, biotechnology, analytical chemistry and other related specialties;

  • Bachelor degree requires at least three-year experience in biological pharmaceutical activity testing, and Master degree requires at least one year experience in biological pharmaceutical activity testing;

  • Proficient in ELISA and cell activity detection skills;

  • Has strong experimental operation ability, strong hands-on ability, and be serious and responsible for work;

  • Proactive work and a strong sense of responsibility. Have a good team spirit and communication ability;

  • Good English writing and reading ability.