Professional：

1. Associate degree in pharmacy, mechanical engineering, or related fields from a full-time program.

2. Strong sense of responsibility and teamwork.

3. Prior work experience preferred.

Work Location: Taizhou Medical City

Submission Email: bin.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Responsible for production operations of solid dosage forms (capsule filling, wet granulation, aluminum-plastic packaging, etc.).

2. Follow SOPs to perform operations and complete production records.

3. Maintain, clean, and service equipment as required.

4. Assist in equipment validation, process validation, cleaning validation, etc.

5. Report anomalies and deviations in a timely manner, take necessary emergency actions, and participate in root cause investigation and analysis.

Professional：

1. Associate degree or above in mechanical, electrical, or related fields from a full‑time program.

2. At least three years of equipment maintenance experience in a pharmaceutical solid dosage manufacturing workshop.

3. Proficient in maintenance skills for granulation lines, capsule fillers, blister packaging machines, and similar equipment.

4. Hold a valid electrician certificate; have basic knowledge of PLC and HMI.

5. Proficient in MS Office and CAD software.

6. Strong sense of responsibility, rigorous and efficient work attitude, good teamwork and communication skills.

Work Location: Taizhou Medical City

Submission Email: bin.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Manage, maintain, and qualify process equipment in the solid dosage manufacturing area.

2. Maintain company equipment records and equipment status labeling.

3. Develop preventive maintenance plans for process equipment and complete them on schedule.

4. Organize qualification and re‑qualification of assigned equipment.

5. Perform annual reviews of critical equipment.

6. Responsible for specialized lubrication and cleaning of process equipment.

7. Assist in equipment and instrument selection and acceptance.

8. Assist in maintenance of utility system equipment and QC instruments.

9. Assist in electrical system maintenance and modification.

10. Conduct daily inspections and maintenance of facility and premises in assigned areas.

Professional：

 1. At least 2 years of experience in chemical drug submission and registration, with responsibility for or substantial participation in NDA submission and registration; experience in clinical‑stage drug registration is preferred.

2. Bachelor's degree or above in pharmacy or a related field.

3. Familiar with registration regulations, technical guidelines, and relevant guidance documents of CDE, FDA, and other regulatory agencies.

4. Good command of English listening, speaking, reading, and writing; proficient in using CDE electronic submission software and eCTD.

5. Strong writing skills, communication and presentation abilities, and team collaboration.

6. Rigorous work style, high sense of responsibility, ability to work under pressure, and capable of completing assigned tasks independently.

Work Location: Taizhou Medical City

Submission Email: bin.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Independently draft and review non-technical documents in accordance with current regulations, and review technical documents for compliance and completeness.

2. Responsible for drafting, reviewing, and submitting registration dossiers; follow up on registration testing, registration verification, and the review and approval process.

3. Develop project registration work plans to ensure timely completion of all registration‑required tasks.

4. Communicate with regulatory authorities on submission and registration matters, and promptly resolve or provide feedback on issues arising during the review and approval process.

5. Track and stay up‑to‑date with the latest NMPA/FDA regulatory policies, guidelines, and normative documents.

Professional：

1. Associate degree or above in pharmacy, traditional Chinese pharmacy, chemical analysis, microbiology, or related fields; at least 3 years of experience in a QC laboratory.

2. Familiar with GMP regulations and data integrity requirements for testing; proficient in using precision analytical instruments such as HPLC and GC; able to independently perform physicochemical or microbiological testing.

Work Location: Taizhou Medical City

Submission Email: bin.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Responsible for testing of raw materials, excipients, and packaging materials used in pilot-scale and process validation batches.

2. Be responsible for the inspection work related to technology transfer.

3. Be responsible for the inspection of finished products and related intermediates in the process validation batch.

4. Be responsible for the inspection related to the stability assessment of the process validation batch.

Professional：

1. Bachelor's degree or above in pharmacy, chemistry, mechanical engineering, or related fields.

2. Able to read relevant professional literature, draft or translate relevant English documents.

3. At least 5 years of validation experience in a pharmaceutical factory, familiar with qualification of facility, utilities and equipment (solid dosage forms), computerized system validation, cleaning/instrument validation requirements.

Work Location: Taizhou Medical City

Submission Email: bin.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Responsible for completing project qualification and validation activities, establishing and improving validation protocols, managing and coordinating various departments to execute on‑site validation work.

2. Establish and maintain the validation system, draft the validation master plan and site validation master plan to meet cGMP requirements.

3. Draft and review the validation master plan; review validation documents and records.

4. Perform qualification and validation of equipment, facilities, and analytical instruments.

5. Manage computerized system validation and cleaning validation.

6. Write validation/qualification protocols, risk assessments, and reports, including DQ/IQ/OQ/PQ.

7. Assess and manage validation‑related deviations and change controls.

8. Maintain and manage access permissions for equipment and facilities.

9. Manage periodic reviews and re‑qualification of equipment, facilities, and instruments.

Professional：

1. Bachelor's degree or above in pharmacy, chemistry, or related fields.

2. At least 1 year of QA experience in a pharmaceutical factory, familiar with GMP requirements.

3. At least 3 years of QC work experience, familiar with chromatography systems, QC instruments, etc.

4. Able to read relevant professional documents, draft or translate relevant English documents.

5. Good communication and coordination skills.

6. Strong sense of responsibility, rigorous and efficient work attitude, teamwork and communication skills.

Work Location: Taizhou Medical City

Submission Email: bin.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Assist the quality head in maintaining and building the GMP system of the plant, including updating and reviewing relevant SOPs and quality manuals to ensure compliance with GMP requirements.

2. Be familiar with relevant drug laws and regulations, track regulatory updates, and require internal SOP updates to maintain GMP compliance.

3. Responsible for change control and impact assessment associated with analytical and testing processes, deviation investigation management, and CAPA tracking.

4. Assist in project management, including technology transfer, CDMO oversight, batch record review, product release review, etc.

5. Communicate with department superiors in a timely manner when issues are identified, especially those affecting production, product quality, and compliance. Ensure deviation investigations are resolved thoroughly, completely, and in a timely manner.

6. Review of QC routine testing data, including audit trail review of electronic data; investigation and review of OOS/OOT/OOE results.

7. Apply scientific knowledge to analyze and solve problems.

Professional：

1. Bachelor's degree or above in medicine, pharmacy, biology, nursing, or a related field. Outstanding fresh graduates are also acceptable.

2. Familiarity with ICH/GCP and China GCP regulatory requirements.

3. Proficiency in Microsoft Office and other common office software.

4. Teamwork spirit, good communication, organizational, and coordination skills.

5. Hardworking, responsible, and able to work under pressure.

Work Location: Suzhou Industrial Park

Submission Email: ying.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Responsible for the selection of principal investigators at research sites and the establishment of study budgets.

2. Responsible for selection of clinical trial institutions, preparation of ethics submission documents, signing of clinical trial agreements, and organization of investigator meetings.

3. Follow up on clinical trial progress, assist investigators in resolving issues that may arise during subject screening, enrollment, and follow‑up.

4. Monitor quality at clinical research sites, identify issues, and propose solutions.

5. Track clinical study progress, coordinate site staff and resources, and complete the study according to the project timeline.

6. Submit monitoring reports in a timely manner.

7. Keep the investigator file (ISF/TMF) up to date.

8. Verify the receipt, dispensing, and return of investigational product, and maintain relevant records.

9. Ensure that study data are recorded in the case report forms (CRFs) in a timely, accurate, and complete manner.

10. Close out study sites and assist with inspection preparations at research institutions.

Professional：

1. Bachelor's degree or above; clinical medicine major and master's degree preferred. Experience in pharmaceutical company projects preferred. Proficient in Microsoft Office software. Good communication and presentation skills.

Work Location: Suzhou Industrial Park

Submission Email: ying.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

· Responsible for daily medical affairs and clinical support work.

Professional：

1. Bachelor's degree or above in medicine, pharmacy, life sciences, or related fields.

2. At least 1 year of CRA experience or at least 1 year of clinical research audit experience.

3. Familiar with clinical trial regulations and policies (e.g., regulatory requirements, GCP, relevant guidelines).

4. Good communication and presentation skills, including coordination and communication with internal and external stakeholders and partners.

Work Location: Suzhou Industrial Park

Submission Email: ying.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Responsible for planning and conducting audits, completing audit reports, and following up on the implementation of corrective and preventive actions.

2. Responsible for reviewing and assessing the quality system, as well as the implementation and effectiveness verification of related corrective and preventive actions.

3. Participate in planning, developing, and implementing clinical SOPs to ensure compliance with GCP, regulatory requirements, and international standards.

4. Coordinate training for clinical staff, maintain employee training records, and provide training on clinical trial quality and compliance.

Professional：

1. Master's degree or higher in clinical medicine (oncology-related).

2. Prior clinical work experience, with solid medical knowledge and clinical practice experience in solid tumors preferred.

Work Location: Suzhou Industrial Park

Submission Email: ying.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Responsible for or participate in the drafting and revision of clinical protocols for the company's new drug projects, as well as the preparation of related clinical documents, and assist in resolving medical issues throughout the project.

2. Provide medical support during clinical trials, answering medical questions raised by investigators, subjects, clinical operations, and other departments within the company.

3. Collect and organize literatures and materials for writing clinical study reports, and assist in the drafting and review of clinical reports.

4. Communicate and liaise with CDE reviewers, clinical experts, CROs, CRCs, and other clinical research resources to ensure the smooth progress of clinical studies.

5. Complete other temporary tasks assigned by leadership.