QC TECHNICIAN IN PLANT

QC TECHNICIAN IN PLANT


COMPANY OVERVIEW
Shanghai JW Biotechnology Co., Ltd. (JW) is a biotechnology company dedicated to pursue innovative technology to develop cures for people with serious and life-threatening diseases.
JW has obtained exclusive licenses of multiple patents and other intellectual property owned by the Pasteur Institute and Theravectys for development, manufacture and commercialization of therapeutic products based on lentiviral vectors.
We offer lentiviral vector development, manufacturing and analytical testing for clinical and commercial supply. Our services include Process and Analytical Methods Development, Full GMP Production, with USP and DSP, Fill & Finish, Quality Control & Quality Assurance and Regulatory Support.
The GMP production facility located in Shanghai is dedicated to provide safe and reliable viral vector-based products and CMO/CDMO services, helping to translate early stage research into commercially viable therapies.
In addition, JW has established partnership with the Huashan Hospital to develop leading edge therapies for various cancers such as liver and prostate cancersas well as infectious diseases such as HBV and Tuberculosis.


QC TECHNICIAN IN PLANT


The QC Technician will be working in JW GMP Plant located in Shanghai ZhangJiang Hi-Tech Park. This position will be responsible to execute analytical methods and/or develop analytical methods which are applied to control the product and the manufacturing process of a new therapeutic biological treatment. Both USP and DSP biotechnologies are applied in this production process. This QC technician will be involved in analytical methods development or in Quality Control activities depending of stage of the development of the different project.

Key responsibilities include but are not limited to:
Knowledge in writing and updating QC related regulatory documents in compliance with GMP:
• Analytical methods
• Specification reports
• Tech transfer reports
• Validation reports; method implementation and method developments
• Tracking and implementing pharmacopeia updates.

Requirements:
• Knowledge in biotech or pharmaceutical industry.
• Strong knowledge of GMP practices and related CFDA, FDA and EMEA regulations.
• Excellent skills in report writing.



Best regards
David