Job Responsibilities:
1. Responsible for the overall process development and research of ADC innovation projects from IND to BLA/NDA stage (covering process development and analytical method development of antibodies, purification, preparations, pilot scale-up, technology transfer, production and quality release), and lead the CMC team to complete the IND application of the project (speed and quality meet the requirements of R&D goals and the regulatory requirements of domestic and foreign target markets), BLA/NDA declaration and on-site verification;
2. Responsible for organizing the professional teams of ADC CMC to evaluate the technical difficulty of the project, formulate the process development strategy and implementation plan (R&D plan) of the project, and supervise and coordinate the team to implement the plan and track the progress;
3. Responsible for coordinating the close cooperation between the ADC CMC team and other teams in the promotion of the project, and participating in the scientific formulation of early pharmaceutical druggability indicators in R&D;
4. Responsible for the final review and finalization of the pharmaceutical technical data of the project;
5. Responsible for docking with external CRO and CDMO companies, and supervising the promotion of outsourcing projects;
6. Familiar with NMPA, FDA, EMA and other domestic and foreign registration regulations, able to understand and grasp the latest trends of technical review in a timely manner, and take timely measures in combination with the internal project situation to achieve an optimized R&D strategy;
7. Responsible for solving technical problems of ADC CMC research platform (including cell culture, purification, quality research, conjugation process and other professional technical sectors). This includes in-depth research on existing technologies, organizing or coordinating resources, and solving technical and compliance issues for the team;
8. Responsible for reducing costs, improving efficiency and improving quality, combined with the international development trend of the industry, updating the existing technology platform, and introducing new technology platforms in a timely manner to meet the needs of international development.

Qualifications:
1. Educational requirements: doctoral degree or above, overseas background or relevant work experience in leading biopharmaceutical companies is preferred;
2. Major requirements: biochemistry, bioengineering, molecular biology, immunology, pharmacy or other related majors;
3. Work experience:
(1) Have more than 3 years of experience in antibody and conjugate process development of ADC drugs, as the project leader or core manager, independently presided over the process development project of antibody drug conjugates, and experience in completing BLA/NDA application is preferred;
(2) Familiar with the process development of antibody drug conjugates and the GMP production requirements of samples, understand the process research requirements and development process of new drug development, and be familiar with quality research, quality standard establishment, application data writing and integration, etc.;
(3) Familiar with the work content of different stages of antibody drug conjugate process development, including process initial establishment, optimization, scale-up, in-depth development, process change and process validation, etc., and be good at using the QbD concept to design and guide the process and quality research process and scheme;
(4) Familiar with the relevant laws and regulations of biotechnological drug registration and GMP production and relevant research guidelines.

4. Competency requirements:
(1) Have the ability of management and coordination within and between departments, as well as project management experience in the simultaneous promotion of multiple projects;
(2) Self-driven, with a high sense of responsibility and entrepreneurial spirit;
(3) Have good communication, organization and coordination skills and excellent team management skills;
5. Language requirements: excellent reading, writing and communication skills in Chinese and English.
Additional Information