1. Master’s degree or above in Clinical Medicine, Life Sciences, or related fields;

2. Minimum 3 years of relevant experience in pharmaceutical/biotech companies; experience in clinical work, data analysis, or literature review is a plus;

3. Familiar with domestic and international regulations, ICH, GCP, and other compliance standards;

4. Strong ability in literature research and analysis;

5. High sense of responsibility, good communication skills, and team spirit.

1. Bachelor’s degree or above in Medicine, Pharmacy, Life Sciences, or related fields;

2. Over 5 years of experience in clinical trial project management, with full-process management experience in Phase II clinical trials;

3. Familiar with regulatory requirements from FDA, NMPA, and others;

4. Strong communication skills, ability to handle multiple tasks, and conflict resolution skills;

5. Proficient in project management software (MS Project, Clarizen), EDC systems, and statistical analysis tools.

1. Ph.D. degree in Biomedical Sciences, Bioengineering, Biochemistry, or related fields. Experience in stem cell differentiation and development research is preferred;

2. Fluent in spoken English with strong writing skills in both English and Chinese;

3. Project and team management: Lead R&D projects independently, develop short- and long-term plans, assign tasks, continuously improve workflows, ensure timely project completion, communicate progress effectively, and manage and evaluate team members;

4. Development and innovation: Continuously conduct technical research, actively follow industry trends, overcome technical challenges, and propose innovative solutions;

5. Data and documentation management: Timely organize and summarize R&D data and documents, ensure proper archiving, and maintain data security and integrity;

6. Technical writing: Responsible for drafting and optimizing invention disclosures, academic papers, and project application materials to support intellectual property and technology transfer;

7. Assist other departments or positions with tasks as needed and complete other assigned duties.

1. Bachelor’s degree or above, with at least 3 years of experience in aseptic manufacturing management; experience in cell therapy and commercial-scale production is preferred;

2. Strong aseptic awareness, with solid knowledge of pharmaceutical regulations and GMP standards;

3. Experience in drafting production-related documents, including equipment qualification, aseptic process validation, and other GMP documentation;

4. Proven experience in team management. Responsible for equipment acceptance, commissioning, qualification, validation, and re-validation for production lines.

1. Bachelor’s degree or above in Bioengineering, Biotechnology, Pharmaceutical Engineering or other related disciplines.

2. Responsible for technology transfer related work; minimum of 5 years of experience in process development and MSAT. Experience in production and quality management is preferred.

3. Responsible for conducting various risk assessments in the Production Management Department, such as shared facility assessment and CCS.

4. Responsible for formulating work plans for product process optimization, process change, and process characterization studies.

5. Responsible for tracking, investigating, and handling quality incidents in the Production Management Department.

6. Compile and summarize qualification/validation plans, track validation progress, and liaise with the QV team.

1. Bachelor’s degree or above in Bioengineering, Biotechnology, Pharmaceutical Engineering or other related disciplines.

2. Responsible for performing process operations including cell seeding, culture and trypsinization, and filling in relevant records in strict compliance with GMP requirements.

3. Responsible for the preparation of self-formulated solutions.

4. Responsible for drafting and revising documents related to the position, as well as undertaking cleaning and equipment maintenance work.

6. Assist the MSAT Department in completing research projects such as process optimization and process characterization.

7. Participate in the tracking and investigation of quality events in the department, including deviations, changes and CAPA.

8. Experience in operating isolators is preferred.

1. Bachelor’s degree or above in Biochemistry, Cell Biology, Pharmacy, Pharmaceutical Analysis or other related disciplines.

2. Responsible for collaborating with the R&D laboratory to conduct transfer and validation of product testing methods.

3. Responsible for completing product testing work, filling in original test records and various on-site auxiliary records, judging test results, and taking responsibility for the authenticity and accuracy of original test records and test results.

4. Responsible for formulating/revising/improving product quality standards and analytical methods as required.

5. A minimum of 2 years of testing experience in pharmaceutical companies or cell biology-related fields, with proficient operation skills of various testing instruments. Experience in new laboratory establishment in pharmaceutical factories, or experience in analytical method validation and transfer is preferred.

1. Bachelor’s degree or above in Pharmacy, Chemistry, Cytology, Molecular Biology or other related disciplines.

2. Be responsible for and capable of independently performing physicochemical testing on samples including pharmaceutical water (purified water, water for injection), packaging materials, and finished products (including HPLC-based content determination, identification, impurity analysis, etc.), as well as filling in original test records and various auxiliary records.

3. Be responsible for and capable of independently conducting sampling of pharmaceutical water and packaging materials; collaborate to complete the qualification and validation of physicochemical testing methods for materials.

4. Be responsible for formulating/revising/improving the quality standards and testing SOPs for raw and auxiliary materials, packaging materials, and pharmaceutical water (purified water, water for injection) in accordance with pharmacopoeia, registration standards, regulations and company requirements.

5. Be responsible for drafting SOPs for relevant instruments and equipment, undertaking their routine maintenance, and cooperating to complete the validation and metrological verification of testing-related instruments and equipment.

6. A minimum of 2 years of experience in physicochemical and biochemical testing in pharmaceutical enterprises, with proficient operation skills of various testing instruments. Experience in new laboratory establishment in pharmaceutical factories is preferred.

1. Bachelor’s degree or above in Pharmacy, Chemistry, Bioengineering, Food Science or other related disciplines.

2. Responsible for sample management, reagent and consumable management, document management, training management and other related work.

3. A minimum of 2 years of relevant work experience; proficient in testing methods specified in pharmacopoeias including ChP, USP and EP. Candidates with experience in compiling GMP documents are preferred.

4. Possess sound experimental data processing capabilities, and be proficient in using office software as well as LIMS.

1. College diploma or above; minimum 2 years of filling-related work experience. Experience in isolator filling is preferred.

2. Proficient in aseptic operations; responsible for cleaning and sanitizing the filling area, as well as completing relevant records.

3. Responsible for drafting and revising position-related documents; assist in investigating position-related quality incidents.

4. Assist the Equipment Department and Validation Department in conducting equipment maintenance, metrological verification and validation work.

1. Bachelor’s degree or above in Biology, Pharmaceutical Science, Chemical Engineering, Pharmaceutical Equipment or other related disciplines.

2. Responsible for the validation of HVAC systems, purified water systems and process gas systems in newly built facilities.

3. Responsible for the validation of cell therapy-related process equipment, testing instruments and CSV.

4. Responsible for drafting APS and PPQ protocols, coordinating and executing the qualification process, as well as completing the final validation reports.

5. Responsible for the validation of GMP procedures in sterile pharmaceutical manufacturing facilities.

6. Responsible for the maintenance of validation system documents and drafting SOPs for validation equipment.

7. A minimum of 3 years of experience in pharmaceutical validation work. Experience in participating in validation projects for newly built pharmaceutical plants is preferred.

1. Bachelor’s degree or above in Biology, Pharmaceutical Science, Chemical Engineering or other pharmaceutical-related disciplines.

2. Responsible for drafting and reviewing GMP-compliant documents, as well as managing company documents and archives.

3. Responsible for maintaining the company’s training management system.

4. Responsible for supplier file management, supplier quality assessment and auditing, and drafting quality agreements.

5. Responsible for organizing internal and external audits.

6. Responsible for establishing and implementing the quality management system, conducting quality system reviews, and compiling review reports.

7. A minimum of 3 years of experience in quality system management. Experience in participating in quality system establishment for newly built pharmaceutical plants is preferred.

1. Master’s degree or above in biomedicine-related disciplines.

2. Formulate and implement intellectual property filing strategies in accordance with the company’s R&D pipeline and business objectives, and provide systematic IP protection solutions for innovative drug projects.

3. Conduct technical communication with the R&D department, carry out patent mining and portfolio planning around company projects, and guide R&D personnel to prepare technical disclosure documents.

4. Responsible for patent search and analysis, FTO analysis, as well as patentability and validity assessment for the company’s ongoing R&D projects.

5. Responsible for drafting patent application documents, responding to office actions, handling patent reexamination and invalidation proceedings, etc.

6. Hold a valid Patent Agent Qualification Certificate; proficient in Chinese patent laws and regulations. Experience in handling foreign-related patent matters is preferred.

7. A minimum of 6 years of practical experience in patent affairs, with the ability to independently handle various patent-related work. Candidates with dual experience as patent examiners and in-house/corporate counsel roles are preferred.

1. Master’s degree required. Candidates with 1–3 years of relevant work experience are preferred. Hands-on experience in molecular biology and cell biology operations is essential.

2. Proficient in routine laboratory techniques including flow cytometry, qPCR, and immunofluorescence; capable of independently performing related experiments with consistent and stable results.

3. Communication & Problem-Solving Skills: Ability to identify and resolve experimental issues, demonstrate independent logical thinking, and maintain smooth and timely communication with the team.

4. Data & Document Management: Timely collate, summarize, sort out and archive experimental data and documents to ensure data security and integrity.