Job responsibilities:

1. Able to independently undertake projects or lead a team to undertake quality research work for multiple projects, formulate a reasonable quality research plan and carry out orderly according to the established plan;

2. Be able to scientifically analyze and effectively solve various problems encountered in the quality research of the project in charge;

3. Keep abreast of and track the latest progress of related topics, and promptly put forward constructive opinions on the project to the team leader/director of the department;

4. Ensure the compliance of research data and complete the sorting of various data materials in time;

5. Proficiency in operating HPLC, GC, UV, IR, moisture analyzer, dissolution analyzer and other analytical equipment, and do a good job in the use, maintenance, verification and calibration of the equipment;

6. Timely understand and follow up the latest requirements of the regulations and guidelines for drug registration (including CFDA, ICH, FDA, EMA, etc.), master the writing and sorting of declaration materials, and be able to independently compile registration declaration materials and original records

7. Other tasks arranged by the leader.

Qualifications:

1. Pharmaceutical analysis and other related majors, with a doctorate degree of 1 year or more, a master's degree of 2 years or a bachelor degree of 3 years of relevant work experience

2. Familiar with drug application and registration regulations and related guiding principles, have strong methodological development and method verification capabilities, and be familiar with quality research, quality standard formulation and new drug application data writing;

3. Be able to search and use various chemical documents and patents, and be familiar with the pharmacopoeias of various countries (USP, CP, EP, JP, BP, etc.);

4. Have good communication skills and organization and coordination skills;

5. Strong stress resistance, good communication skills and teamwork spirit.

Job responsibilities:

1. Implement relevant experimental work of chemical raw materials, intermediates and preparations as required;

2. Assist synthesis personnel and preparation personnel in sample analysis and other testing work;

3. Responsible for quality research work, development methods, methodological research work and establishment of corresponding quality standards and stability research work for R&D projects;

4. Completely record and sort out the original test records and related documents to ensure their authenticity and completeness, and write application materials for drug analysis;

5. Proficiency in operating HPLC, GC, UV, IR, moisture analyzer, dissolution analyzer and other analytical equipment, and do a good job in the use, maintenance, verification and calibration of the equipment;

6. Search and use various chemical documents and patents, and be familiar with the pharmacopoeias of various countries (USP, CP, EP, JP, BP, etc.).

Qualifications:

1. Bachelor degree or above in relevant majors such as drug analysis;

2. Two years or more of chemical drug R&D and analysis experience, able to independently complete analytical method development and verification; more excellent undergraduate students can also be considered;

3. Employees who expect to develop in the direction of drug analysis and quality standard establishment;

4. Strong ability to withstand pressure, good communication skills and teamwork spirit.

Job responsibilities:

1. According to the requirements of the project, assist the team leader or independently complete the research of the small-scale, pilot-scale and trial production process of API preparation. Complete research work such as confirmation of compound structure;

2. Compose the corresponding application materials and sort out the original records;

3. Undertake the corresponding on-site verification in the registration application;

4. Assist the team leader to conduct research on new drugs and generic drugs.

Qualifications:

1. Master's degree or above in medicinal chemistry (synthesis) or related majors, undergraduate 3 years or above in drug synthesis-related work experience, more excellent undergraduates can also be considered;

2. Ability to independently design and carry out multi-step organic synthesis reactions;

3. Familiar with and use common compound separation and purification techniques and structure identification methods in laboratories, such as NMR, HPLC, MS, LC-MS, IR, etc.;

4. Ability to search and use various chemical documents and patents skillfully;

5. Have a sense of responsibility, project management experience, professionalism and innovation.

Job responsibilities:

1. Develop project plans according to leadership requirements, coordinate and track the research and development progress of various projects in the department, supervise and check the quality of the research projects, and cooperate with relevant departments to submit project progress;

2. Responsible for team management within the group, including work assignment coordination, organizing technical research, and ensuring that the project is implemented in an orderly manner according to the plan;

3. Responsible for the review of the application materials of the registered project, the communication with CDE review experts before and after the application materials are submitted, and the tracking of the application registration progress;

4. Responsible for the supervision and verification of the implementation of the project contract;

5. Filing management of application materials, meeting materials and other related documents of department management;

6. Responsible for the standardized management of the laboratory, including the safety and sanitation of the laboratory, the in-out management of various materials and consumables.

Qualifications:

1. Doctor degree or above in medicine majors (pharmacy, pharmacy, pharmacology, (natural) medicinal chemistry, Chinese pharmacy, etc.), and masters with relevant experience can also be considered;

2. With more than 5 years of relevant drug development experience, familiar with the drug development process, and independently complete the complete development of a project;

3. Have certain experience in drug declaration and registration, and be familiar with drug policies and regulations, pharmaceutical intellectual property rights and other relevant laws and regulations;

4. Have certain laboratory management experience, familiar with GMP, GLP and other related management regulations.