1. Responsible for organizing verification review and drafting annual verification plan;
2. Responsible for organizing confirmation and verification of related risk assessment, and participating in collinear risk assessment;
3, responsible for cleaning confirmation and verification plan and report drafting, data statistics and analysis;
4. Responsible for and participate in the verification and re-verification of plant facilities, equipment, instruments and computerized systems;
5. Participate in the URS audit of the new stock solution and preparation production line, RA, DQ, FAT, SAT, IQ, OQ, PQ, etc.;
6. Investigate and handle deviations and changes in the verification process;
7. Participated in internal and external audits related to company verification, and was responsible for the implementation and tracking of CAPA verification;
8. Participate in the revision and improvement of the quality system verification and confirmation file system, verify the interpretation and training of the latest requirements of relevant regulations and guidelines;
9. Complete other work arranged by superiors。

1, biology, pharmacy and other related professional college/bachelor degree or above, more than 3 years of biopharmaceutical or sterile drug industry verification experience, must have clean verification work experience, with public engineering, computerized system verification experience is better。
2, familiar with the 2010 version of GMP and its appendix for verification and confirmation requirements;Familiar with EU, FDA and WHO GMP, ICH, PDA, ISPE and other guidelines。
3、 I love verification work, have good professional quality, serious and careful, adhere to principles, have good communication and coordination skills and team spirit, have the ability to learn quickly, can adapt to the fast pace of work, can adapt to the temporary overtime and a small amount of business trips in the project stage, and have positive initiative。
4、 Proficient in Office software, common drawing software, FMEA common risk assessment tools and statistical analysis tools。
5、 Good reading and writing skills in both Chinese and English。

1. Responsible for implementing the project purification process development plan, making experimental plans, and preparing materials, equipment, personnel, etc.;
2. Supervise and actually participate in the implementation according to the experimental plan, and reasonably arrange the work and work progress of the staff under my jurisdiction;
3, control and supervise the operation and process parameters during the experiment to ensure the effective implementation of the experiment plan;
4, responsible for the integrity and quality of purification process development data and documents, write pre-clinical research application materials, participate in on-site verification and answers;
5, assist the department head to control and manage the purification process development process of each project;
6. Participate in the optimization and continuous improvement of departmental rules and regulations and process development process, and solve technical problems encountered in process development;
7. Assist the department head in the management of laboratory instruments, safety and health;
8. Timely completion of job-related training;
9. Complete other tasks arranged by the leader。

1, Pharmacy, microbiology, bioengineering related major, bachelor degree or above, 3-5 years of work experience in the field of protein purification, with antibody drug process development experience is preferred;
2, familiar with downstream purification technology, including chromatography, deep filtration, virus removal filtration and ultrafiltration technology;
3, familiar with various purification process development principles, proficient in various fillers and membrane properties, skilled in the use of protein purification chromatography system;
4. Have a certain understanding of GMP regulations and requirements, NMPA, FDA, EMA, ICH and other regulations and management regulations;
5, with analysis and problem solving skills, communication skills and team spirit;
6. Good English reading and writing skills。

1. Responsible for the management and maintenance of the company's external relations, including but not limited to investors, government, media, industry associations, etc.;
2. Responsible for the planning, establishment, management and external publicity of the company's public image, such as official website, public account, industry journal, etc.;Responsible for the company's external publicity materials planning, writing, review, release;
3. Lead, cooperate and coordinate external public relations companies to monitor public opinion and manage crises;
4. Plan and implement positive investor relations programs and cooperate with the company's information disclosure;
5, assist the company's employer brand establishment and other related work。

1. Bachelor degree or above, major in journalism, media, Chinese language and literature is preferred;
2, more than 6 years of relevant work experience, pharmaceutical, biotechnology industry experience is preferred;
3, with excellent communication and coordination skills, good response and crisis handling ability;
4. Strong planning, organization and writing skills。

1. Provide internal legal advice and support for the company's operation and management, and improve the company's legal management system;
2. Responsible for the coordination of external legal affairs, liaison and cooperation with external lawyers and legal advisers;
3. Assisted in handling the company's three documents and information disclosure of listed companies;
4. Conduct compliance review of the company's contract information, information disclosure documents and important rules and regulations;
5. Cooperate in organizing and planning the compliance and legal risk knowledge training for employees。

1. Bachelor degree or above, major in law, pass the national judicial examination or have a lawyer's certificate is preferred;
2, more than 8 years of legal related work experience in law firms or companies, pharmaceutical, biotechnology industry experience is preferred;
3. Familiar with the legal process and compliance management of listed companies, IPO participation experience is preferred;
4, familiar with economic law, contract law, company law, patent protection law and other relevant laws and regulations;
5, with excellent oral and written expression skills, logical thinking clear, good analytical skills。