1. Responsible for the implementation of analytical experiments for the development of liposomes and new DDS for FDA and CFDA.
2. Receive, test, store and manage samples in accordance with analytical methods and related SOPs. Solve basic problems during experiments independently.
3. Write analysis and R&D plans and R&D reports in accordance with the standardized format and requirements, record original materials and draft relevant application materials for analysis and development.
4. Review the relevant research results completed by the project, including but not limited to product registration materials, original data, maps, etc.; Cooperate with the registration specialist to complete the technical and regulatory compliance confirmation work involved in product registration.

1.Responsible for the implementation of experiments for the development of liposomes and new DDS the comply with FDA and CFDA.
2.Write the preparation R&D plan and report in accordance with the standardized format and requirements, record original data and draft application materials related to the preparation development.
3. Work with analysts to solve analytical problems related to formulation development.
4. Implement and assist the production department in carrying out the technology transfer and batch production of liposomes and nanoparticles DDS projects at home and abroad.
5. Review the relevant research results completed by the project, including but not limitedto product registration materials, original data, maps, etc.; Cooperate with the registration specialist to complete the technical and regulatory compliance confirmation work involved in product registration.

1. Responsible for drafting and writing various technical documents for the R&D analysis department, such as transfer and validation plans for analysis methods of raw materials and finished products, transfer and validation reports, analysis methods, and quality standards.
2. Responsible for drafting stability research, influencing factor research, forced degradation research, compatibility research, freeze-thaw research plans and reports.
3. Assist in drafting technical documents for the development of formulations, such as formulation process research plans, research summary reports, process trial and pilot batch records, process validation plans and reports.
4. Responsible for drafting laboratory standard operating procedures (SOP), internal guidelines, and other internal management documents.
5. Responsible for drafting CTD format application documents.
6. Responsible for responding to defect declaration letters.
7. Responsible for translating technical documents into English and preparing for international applications.
8. Responsible for managing and updating various technical document templates.
9. Responsible for training on writing technical documents for the R&D department.
10. Responsible for the initial review of technical documents.

1. Responsible for the organization and coordination of abnormal product events at the production site, to ensure that product deviations, changes, and CAPAs are effectively handled, including acceptance, putting forward handling opinions, supervising implementation, tracking and closing;
2. Ensure that product documents: process specifications, verification plans/reports, BPRBCR, etc. are effectively reviewed and meet the requirements;
3. Responsible for on-site inspection of products, ensuring that on-site process operations, hygiene, identification, customization, production records and auxiliary records meet the requirements, and promoting the rectification of non-conforming items;
4. Ensure that product production related verification, including process verification, cleaning verification, etc., supervise the verification process as required;
5. Ensure that deviations, non-conformities and change actions related to release have been effectively dealt with before product release;
6. Ensure that product complaints and returns in the production area are investigated in a timely manner;
7. Conduct regular environmental monitoring of the production clean area;
8. Participate in product quality review.