TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
Under the leadership of the technical director of the department, be responsible for implementing the R & D plan for the physical and chemical analysis methods of the whole or part of the project and have a deep understanding of the technical background information and technical characteristics of the projects;
Establish and validate specific protein physicochemical analysis methods, analyze and solve problems;
Lead a project team or manage an analytical technology platform team according to qualification and ability;
Be responsible for completing the development of analytical methods and product specifications for the entire project to meet the national quality and approval standards for biomedical clinical and commercial production;
Be responsible for the integrity and quality of project documents and data, and be responsible for CMC dossier preparation;
Analytical methods include, but are not limited to, various types of high-pressure liquid phase analysis, capillary electrophoresis analysis, etc.;
Develop new, reliable and efficient analytical methods for proteins and antibodies, and continuously innovate technologies;
Continuously learn and master to follow up on the requirements of international and Chinese regulations and guidelines for biopharmaceutical analytical methods, and be responsible for writing the application materials for drug analysis.
Master's degree (or above) with a background in biochemistry, chemistry, pharmacy, analytical chemistry, bioengineering or biochemical engineering and other related specialties;
The master's degree with more than five three years of relevant research experience; the doctoral candidate has various modern analytical research methods involving certain proteins and antibodies; and have experience in antibody and biological macromolecule analysis is preferred;
Have strong ability to analyze and solve problems, have in-depth knowledge of the chemical characteristics of proteins and antibodies, and have specific operating experience in various modern physicochemical analysis technologies and instruments and equipment;
Be rigorous, diligent, studious, team spirit;
Good English with listening, reading and translating some materials.