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 Physicochemical Analysis

Department :  TechOps
Working place :  Hangzhou
Recruitment :  1
Nature of work :  Full-time
Working years of :  1 to 4 years
Minimum academic :  Bachelor's degree and above
Release time :  16 Oct, 2020
Responsibilities
  • Be responsible for drafting and reviewing the SOPs related to the corresponding physical and chemical methods and the operation and maintenance of precision instruments of biological products;

  • Participate in sample detection and record review to ensure the accuracy and effectiveness of test results;

  • If necessary, be responsible for the development and validation of methods, drafting and reviewing protocol reports and writing and validating 3Q protocols for related equipment; establishing and validating analytical methods including SEC-HPLC, CEX-HPLC, CE, etc.;

  • independently conduct the experiment according to the experimental protocol, follow up the experimental process, and timely communication with the collaborators to ensure the accuracy and reliability of the experimental results;

  • As the responsible person for equipment, be responsible for routine maintenance and PM of equipment. Review of equipment life cycle and track of abnormal events.

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

  • Full-time Bachelor degree or above;

  • Major in pharmaceutical engineering, drug analysis or biotechnology and other related specialties;

  • Have a relevant background in the research or analysis of biological products, and have a basic knowledge background for protein research is superior;

  • Be familiar with the detection and analysis techniques of protein drugs, be familiar with or master the purity and concentration analysis techniques such as SEC, CEX, peptide mapping, glycosylation, cIEF, CE-SDS and UV spectrophotometer, and be able to process, integrate and interpret the analysis results;

  • Understand the guidelines for the development and validation of analytical methods in the Chinese Pharmacopoeia, ICH and others, and have QC experience is preferred;

  • Be familiar with or master various analytical techniques such as high-performance liquid chromatography and capillary electrophoresis, and have experience in mass spectrometry and protein analysis is preferred;

  • Have a team spirit, has relevant projects and personnel management experience is preferred;

  • Good English reading and writing ability, and excellent English speaking is preferred;