Job Responsibilities:

1. Comply with the company's rules and regulations, and observe the confidentiality system;

2. Validation of GMP method for macromolecule analysis according to GMP workflow;

3. Possess good theoretical knowledge of protein macromolecules, and can be proficient in using a variety of protein analysis methods, including column chromatography analysis, a variety of electrophoresis methods, protein quantitative detection methods (such as ELISA), and perform qualitative and quantitative analysis of biological samples;

4. Be able to communicate with relevant professionals and independently solve related problems in the qualitative and quantitative analysis of biological samples using protein analysis methods;

5. According to SOP, accurately and efficiently complete the analysis experiment, experiment record, report writing, file sorting work;

6. Collate and compile IND and BLA application materials with other personnel in the CMC department;

7. Supervise and manage the CMO, complete the verification and transfer of analysis methods, and coordinate the entire process of raw material and preparation production.
 

Job requirements:

1. Possess relevant professional and technical background in biochemistry, molecular biology, pharmacy, undergraduate or postgraduate degree;

2. Possess experience in analyzing protein macromolecule drugs;

3. Experience in IND and NDA declaration is preferred; those who are familiar with GMP production rules and regulations are preferred;

4. Have a good team spirit and the ability to solve problems;

5. Familiar with Microsoft Word, Excel and other office software; have good English reading and writing skills;

6. Abide by the company's regulations and have good professional ethics;

7. Strong communication skills, acceptance and execution ability; serious and responsible, hard work, and hardworking;