Current Openings

Senior Scientist of Antibody Engineering

Job Responsibilities:

1. Engage in relevant experimental work of antibody engineering in the process of new drug development, such as scheme design, experimental operation, data analysis, etc.;

2. Responsible for transforming antigen and antibody molecules from the genetic level, optimizing their expression level or improving activity;

3. Responsible for the construction and expression of bispecific antibodies;

4. Work related to the humanization of antibodies and antibody affinity maturation;

5. Responsible for communication with CRO, follow-up, supervision and other project management work;

6. Complete other tasks assigned by superiors.

job requirements:

1. Doctor degree or above; major in immunology, structural biology, protein engineering, etc.

2. At least 1 year of work experience, or post-doctorate experience, with antibody drug development or CRO work experience is preferred.

3. Have good writing and oral communication skills (Chinese and English).

4. Strong experimental operation ability, serious and responsible, proactive, patient and meticulous, practical and hardworking;

Head of Registration Department

Job Responsibilities:

1. Responsible for the registration strategy of the company's drugs under development (macromolecule biologic drugs in the field of tumors and autoimmune diseases), determine the key points of registration, and control the approval risk;

2. Responsible for the application of drugs, including the sorting, writing, review, and submission of registration materials, organizing expert meetings for defense and on-site assessment;

3. Grasp the overall progress of the project, organize periodic review of the project on a regular basis; be responsible for providing support for the registration technical requirements for the entire process of research and development, and guiding the company's project compliance development;

4. Timely capture, interpret and feedback the updates of CFDA registration related policies and product declaration information, provide suggestions for company decision-making and conduct internal training within the company;

5. Maintain good communication and management with various departments and cooperative units in the process of project development, application, and approval;

6. Establish and optimize rules and regulations and work processes related to registration regulatory affairs.

7. Cooperate with the clinical operation department and external suppliers to complete the application of the genetic office of the clinical trial project and the registration and publicity of the clinical trial project

job requirements:

1. Bachelor degree or above in medicine related majors;

2. More than 3-5 years of drug registration experience, with experience in IND application, and experience in IND application for antibody drugs in the field of autoimmunity or tumor is preferred;

3. Proficient in Chinese drug management and registration and other relevant regulations and technical guidelines, familiar with the drug registration application process and various links, the writing and review of application materials, and the ability to communicate with CFDA experts in depth;

4. Strong drug registration information retrieval, analysis and research capabilities, able to accurately understand foreign related regulations and documents such as FDA and EMA;

5. Have good communication skills, analytical judgment and problem-solving experience; clear thinking and rigorous.