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Job Summary

Company
Canton Biologics​

Location
Guangdong, China​

Job Type
Contract (1 year)

Pay Rate
Competitive Salary

Years of Experience
Experienced(2-5 Years)

Job Reference Code
J1801054

CQA Director

Posted on Jun 26, 2019
Canton Biologics
Guangdong, China

About Company:

Canton Biologics is a biotechnology company specializing in research and development of protein products. Founded in 2015, Canton Biologics focuses on developing and manufacturing monoclonal antibodies, bispecific antibodies and other therapeutic recombinant proteins. The company’s headquarters are located in Guangzhou, China, with a holding subsidiary in Switzerland and a CMO and an R&D unit in Foshan, China. With a protein drug production line that meets the FDA, EMA and the Chinese cGMP standards, Canton Biologics is building the most efficient biopharmaceutical R&D and production platform in South China.


Job Profile:

1. Responsible for QC work during drug research and development and responsible for formulating QC research work plans

2. Responsible for managing the personnel of the CQA team, ensuring the completion of R&D tasks, formulating individual work plans, providing guidance on the technical challenges arising in the R&D process and organizing the drafting and review of IND materials on quality

3. Responsible for the day-to-day management of the laboratory, and rational allocation and rational use of resources and personnel according to project needs

4. Responsible for reviewing analytical test data and original experimental records

5. Responsible for drafting and reviewing method validation protocols and standard operating procedures (SOPs)

6. Supporting the daily research work of the R&D department and the Quality department, such as biological activity assays, sample purity determination, etc.

7. Responsible for departmental training, team building, performance evaluation and other departmental affairs


Job Details:

Requirements:

  • MSc or above, BSc in pharmacy, pharmaceutical engineering or other similar fields
  • 3+ years of working experience in biopharmaceutical quality research
  • Experience in analytical method development, analytical method validation, quality standard establishment
  • Experience in drafting documentation for drug quality and stability sections of IND application - at least one set of documents drafted for an approved project
  • Expertise in use of analytical instruments for HPLC/GC/LC-MS, and skills in basic maintenance and troubleshooting of these instruments.
  • Familiarity with ICH, GMP, FDA and CFDA-related guidelines and quality management systems, proficiency in English reading
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