Global Biopharmaceutical company originally from Europe and recently expanded in Japan. The company specializes in novel antibody technology for treatment of Cancer.
The position is responsible for all the operational matters related to CMC activities under the supervision of Head of QA / CMC Japan. This position covers not only CMC related activities but also helps support various operational matters for Regulatory Affairs & QA functions.
Make a strategic Japan NDA plan for CMC and execute.
Execute post approval lifecycle management.
Establish solid supply chain in Japan.
Grasp the latest domestic and overseas technologies and regulations.
Depth understanding for Manufacturing / testing, prepare high-quality CTD.
Be involved in CDT meeting.
Bachelors Degree and above (Advanced degree is a plus, Pharmacist License is a plus)
At least 10 years Industry experience in CMC, either in RA and / or QA.
Experience for preparing M1.2 and 2.3 based on Global M3, Batch record, SOP, Validation report, stability report, etc. preferably both small molecule and biological products (especially for mAb and ADC).
English (business level).
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