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不良事件/反應(yīng)報(bào)告

https://www.walvax.com/public_information/?type=5&id=1

不良事件/反應(yīng)報(bào)告

Corporate Culture

As a high-tech company engaged in the research and development of new vaccines, Zerun Biotech aims to “provide advanced vaccines that meet international standards for the people of China and the world”, and adheres to the philosophy of “openness, inclusiveness, co-creation and sharing”. We promote the steady development of the company through “excellent leaders, professional and efficient team, high quality and efficiency of output, internal and external recognition, retention and attraction of talents”, and:

  • Supply competitive salary and benefits, attracting professional talents from home and abroad;
  • Provide working environment filled with humanity and harmonious interpersonal relationships, respect and trust employees;
  • Offer a broad career development platform for talents of both virtues and talents.

Job Opportunity

Talent Concept

Zerun regards talents as the source of innovation and development of the company, people-oriented, respect and trust employees, appreciate and encourage innovation, and advocate continuous pursuit of excellence.

 

Salary and Benefits

Generous salary and incentives:Competitive salary,Year-end Bonus&Performance Bonus&Project Bonus,Social Insurance/ Housing Provident Fund,Patent and Publication bonus.

Sound welfare guarantee:Annual Vocations, Sick Leave,Family visit reimbursement,Allowance for Transportation/Meal, Festival gifts,Commercial Health Insurance,Annual Physical Examination,team vacation.

Diversified development platform:Job training and mentor program,Funding for In-service part time degree education,Dual career development and promotion opportunity,Encourage creative thinking and self-improvement,Advanced International Interaction opportunities.

In harmony culture and atmosphere:Open&respective&encourage working environment,Embrace both Eastern and Western Cultures,Rich team and employee cultural activities.

 

Join Us

Zerun has broad development prospects. Talents are our most important resources. We are looking for the professionals with knowledge, ability, passion, responsibility ,and willing to participate in the biomedical industry,grow up with Zerun.
If you are interested in working for the company, please send your CV to us and feel free to contact us at zerunhr@walvax.com.

  • (Senior) Analytical Methods Development Engineer

    2023/06/01

    Responsibilities

    1. Responsible for designing and exploring, developing and confirming analysis methods, optimizing existing methods, and completing relevant technical reports.
    2. Responsible for the establishment of R&D quality standards and the stability research in new drug R&D.
    3. Complete routine inspection and daily work and R&D project inspection and analysis tasks to ensure that the corresponding R&D projects are successfully completed on schedule.
    4. Complete relevant method verification and transfer, complete SOP formulation and related transfer handover and training.
    5. Complete standardized research and analysis reports and experimental records, summarize and analyze experimental data, and be responsible for writing relevant reports.
    6. Provide analytical data and support for process and R&D departments, and assist in solving problems encountered in process development and improvement.

      

    Preferred Characteristics

    1. Master's degree or above, major in biochemistry, pharmacy, chemical analysis, biomedicine, biotechnology, etc., and more than 3 years of analytical testing work experience or analytical method development experience in biomedicine and related industries.
    2. Those who have work experience in large-scale analysis platforms such as liquid phase, CE, ELISA, SDS-PAGE, molecular biology/cell, etc. are preferred; be able to operate test equipment and instruments proficiently, and be familiar with the maintenance of analytical instruments.
    3. Familiar with the Pharmacopoeia and other guiding principles, familiar with the relevant knowledge of GMP quality management and quality control; familiar with the basic requirements for application materials and test records in new drug research.
    4. Possess the ability of literature retrieval, and can independently design and explore, establish and verify analysis methods according to relevant reference materials.
    5. Possess the ability to read, write and translate English materials and teamwork, work proactively, rigorously, with an independent spirit and a high sense of responsibility.

     

  • (Associate) Formulation Engineer

    2023/06/01

    Responsibilities

    1. Assist in the research on the dosage form, prescription, and stability of pharmaceutical preparations, and prepare the preparation samples required by the project.
    2. Assist in the research on the production process of pharmaceutical preparations (process optimization, verification and scale-up, etc.).
    3. Participate in literature research, organize and analyze experimental data, write and check data, and be responsible for the authenticity, integrity and standardization of original experimental records.
    4. Participate in equipment operation and maintenance; participate in the daily management and safety management of the laboratory.
    5. Other work in support of the department.

      

    Preferred Characteristics

    1. Bachelor degree or above, major in pharmacy, biology, chemistry, etc., familiar with commonly used pharmaceutical websites and databases, and 1 year or more working experience in preparations.
    2. Master in aseptic operation, freeze-drying, adjuvant or nucleic acid chemical synthesis (choose one out of four), GC, HPLC, stability research, etc., or those who can operate commonly used preparation equipment is preferred.
    3. Have good communication skills, strong sense of responsibility, professionalism, and ability to work under pressure.

     

  • (Assistant) Purification Engineer

    2023/06/01

    Responsibilities

    1. Complete the daily solution preparation, routine testing, and chromatography experiment operations in the laboratory.
    2. Participate in the daily management of the laboratory, including document organization, maintenance of laboratory instruments, etc.
    3. Actively participate in the formulation of experimental strategies by senior engineers and put them into practice.
    4. Complete the experimental plan formulated by the senior engineer.
    5. Analyze the experimental data and give feedback to the senior engineer in time.

      

    Preferred Characteristics

    1. Chemistry, pharmacy, biology and other related majors, bachelor degree or above, 1 year or above purification related work experience.
    2. Working experience in biomedical companies is preferred.
    3. Able to read English literature proficiently.
    4. Good work coordination, communication and teamwork skills.

     

  • (Associate) Fermentation Engineer

    2023/06/01

    Responsibilities

    1. Bachelor degree or above, major in biotechnology, biopharmaceuticals, microbiology, etc., with 1 year or more working experience in fermentation.
    2. Sample detection during fermentation, including but not limited to protein content determination, antigen content determination, SDS-PAGE, Western-Blot, HPLC, etc.
    3. Do a good job in the daily inspection and maintenance of the equipment of the position, and be responsible for the cleaning of the equipment of the position and the cleaning of the work area.
    4. Other work in support of the department.

      

    Preferred Characteristics

    1. Bachelor degree or above, major in biotechnology, biopharmaceuticals, microbiology, etc., with 1 year or more working experience in fermentation.
    2. Understand fermentation related knowledge, and those with fermentation related work experience are preferred.
    3. Have a good team spirit, sense of responsibility and initiative.

     

  • (Senior) Fermentation Engineer

    2023/06/01

    Responsibilities

    1. Write plans for process optimization, characterization, or amplification according to project requirements, and participate in relevant experiments to complete data analysis and report writing.
    2. Participate in the production of clinical samples, prepare GMP production related documents, train production personnel, and complete sample production according to the production plan, review batch production records and other related records.
    3. Participate in the process technology transfer during the industrialization stage, assist the industrialization team in relevant design and equipment selection, support the production team in completing process validation, and solve technical problems encountered during the technology transfer process.
    4. Participate in the writing and translation of WHO PQ/BLA application materials.

      

    Preferred Characteristics

    1. Bachelor's degree or above in bioengineering, microbiology, biochemical engineering, or fermentation engineering.
    2. At least 5 years of undergraduate/3 years of master's experience in microbial fermentation process development.
    3. Having a solid professional theoretical foundation and mastering fermentation process optimization and process amplification techniques.
    4. Familiar with the structure and use of different levels of fermentation tanks (from small-scale to pilot scale).
    5. Proficient in literature review in both Chinese and English, possessing good scientific research abilities and literacy.
    6. Have good communication, teamwork skills, English expression and writing skills.

     

  • Preparation Assistant Engineer/Technician

    2023/06/01

    Responsibilities

    1. Participate in the GMP sterile preparation production project in accordance with the production instructions, and execute the production operation of the position in accordance with the production plan.
    2. Perform preparation technology transfer related work, independently conduct process parameter testing, technology transfer and experimental plan/report writing.
    3. Drafting and revising relevant GMP documents, and participating in GMP training; ensuring the GMP compliance of the position, reporting changes and deviations in accordance with the GMP process, and implementing CAPA, etc.
    4. Responsible for post operation and daily cleaning and maintenance (including equipment and workshops), support the implementation of the maintenance of the engineering department, and ensure the normal operation of production, and the operation and work flow in compliance with regulations.
    5. Participate in the upgrading of preparation hardware of the pilot test department and the improvement of the GMP system.
    6. Participate in the daily division of labor in the pilot test department, and support the pilot production and industrial preparation production related work.

     

    Preferred Characteristics

    1. College degree or above in pharmacy, biology, chemistry and other related majors.
    2. Have certain relevant experience in the development of preparation production process parameters, technology transfer, etc., have been engaged in or familiar with the relevant regulatory requirements of GMP production of sterile preparations, and have more than 1 year of GMP production experience is preferred.
    3. Familiar with the production process of small-volume injections (cillin bottles, pre-filled injections).
    4. Have a good team spirit, communication skills and organizational skills.
    5. Able to accept overtime, transfer time off and business trip arrangements.

  • Clinical Quality Specialist

    2023/06/01

    Responsibilities

    1. Continuously update and improve the database of clinical research regulations/policies/guidance principles.
    2. Responsible for quality control, data verification and audit work on clinical trial sites and third-party laboratories.
    3. Responsible for organizing and coordinating CFDI on-site inspection work.
    4. Responsible for the collection, QA, sorting and filing of documents during the clinical trial.
    5. Responsible for reviewing the compliance content of clinical institutions and supplier contracts.
    6. Improve department SOP, quality management system and training system.
    7. Departmental support work.

     

    Preferred Characteristics

    1. Bachelor degree or above, major in pharmacy, biology, pharmaceutical work, medicine, etc., English CET-4 and above.
    2. Good rapid learning and understanding ability, risk prediction ability, organizational coordination and problem-solving ability.
    3. Those with CRA (Clinical Monitor) or CTA (Clinical Research Assistant) work experience are preferred.
    4. Be serious and responsible in doing things, adhere to principles, and have excellent professional ethics and literacy.
    5. Able to work under certain pressure and adapt to a certain frequency of business trips.

  • International Cooperation and Business Development Supervisor/Specialist

    2023/06/01

    Responsibilities

    1.Assist the department head in liasing with international institutions/companies, and carrying out international business and cooperation
    (1)Assist in the communication with international cooperation institutions/companies;
    (2)Assist in regular or special meetings with international institutions/companies, and assist in reporting and communicating on project progress;
    (3)Draft relevant Chinese and English documents involved in the international cooperation process, and provide translations as needed;
    (4)Assist the department head in developing new international cooperation opportunities, conducting business negotiations, signing contracts, supervising contract execution, and handling related business matters.

    2.Assist the department head in finding and establishing cooperative relationships
    (1)Assist the department head in establishing cooperative ties with potential partners;
    (2)Research potential partners, and assist the department head in visiting or inviting partners for further negotiations;
    (3)Coordinate resources to promote cooperation and contract signing, etc.

    3.Industry information analysis
    (1)Assist the department head in collecting, analyzing, and organizing domestic and foreign industry-related policies and market information;
    (2)Regularly output industry information reports.

     

    Preferred Characteristics

    1.Majors in business, biopharmaceuticals, law, or related fields; master's degree; preference for candidates with overseas study experience
    2.Familiar with vaccine or biopharmaceutical industry-related knowledge; proficient in English listening, speaking, reading, and writing skills
    3.Two or more years of work experience in the biopharmaceutical industry is a plus
    4.Possess good writing skills and the ability to create and present PowerPoint presentations
    5.Possess strong communication and teamwork abilities