Job Description:
1. Responsible for the company's corresponding reagent kit research and development projects, conduct preliminary project research, project establishment, project implementation, project completion, and complete the tasks according to the project schedule.
2. Responsible for the development, optimization, and verification of in vitro diagnosis methods for mass spectrometry products.
3. Responsible for the output of system documents during the whole kit R&D process, including the organization, writing, and reporting of submission materials for R&D products.
4. Assist in the completion of product declaration work such as production transformation, clinical trials, system assessment, registration, and submission for inspection.
5. Training of production line personnel and technical support staff.
Qualifications and Experience Requirements:
1. Academic qualifications: Master's degree.
2. At least 2 years of research and development experience in mass spectrometry IVD, individually responsible for related mass spectrometry kit projects, proficient in the development of clinical mass spectrometry methods, and familiar with the in vitro diagnosis industry.
3. Knowledge of in vitro diagnostic product laws and regulations and relevant quality systems.
4. Strong logical thinking and execution ability, and good product consciousness.
5. Experience in developing and registering complete mass spectrometry kit products is preferred.
Job Description:
1. Responsible for the company's corresponding regent kit research and development projects, conduct the preliminary project research, project establishment, project implementation, and task completion according to the project schedule.
2. Responsible for the development, optimization, and verification of the product methods for mass spectrometry in vitro diagnosis.
3. Responsible for the output of system documentation during the whole kit R&D process, including the organization, writing, and reporting of submission materials for R&D products.
4. Assist in the completion of product declaration work such as production transformation, clinical trials, system assessment, registration, and submission for inspection.
5. Training of production line personnel and technical support staff.
Qualifications and Experience Requirements:
1. Academic qualifications: Master's degree;
2. At least 2 years of research and development experience in mass spectrometry IVD, individually responsible for mass spectrometry kit related projects, proficient in the development of clinical mass spectrometry methods, and familiar with the in vitro diagnosis industry.
3. Knowledge of in vitro diagnostic product laws and regulations and relevant quality systems.
4. Strong logical thinking and execution ability, with good product awareness.
5. Experience in developing and registering complete mass spectrometry kit products is preferred.
Job Description:
1. Standard production operations in accordance with the standard operating procedures.
2. Proficiency in the use of the production equipment related to the post.
3. Responsible for the day-to-day workshop maintenance, production work, and batch record filling.
4. Self-inspection as required and timely reporting of problems found for processing.
5. Maintain environmental control of the clean room and daily record registration.
6. Complete other tasks assigned by leaders.
Qualification and Experience Requirements:
1. At least one year of related production work experience.
2. Experience in clean room production work and familiarity with medical device regulatory requirements.
3. Good communication, presentation, and learning skills.
4. Hard-working with a sense of responsibility;
5. Possess team spirit.
Job Description:
1. Extract biological samples such as plasma and serum according to the experimental standard specifications and operating procedures, use LC-MS for testing, and judge whether the test data meet the standards.
2. Organize and analyze experimental data and issue the inspection report on time.
3. Responsible for the operation and daily maintenance of mass spectrometer and supporting facilities.
4. Responsible for the maintenance and monitoring of the environment and sanitation of their respective laboratories and public areas and ensure that the experimental environment meets the relevant quality requirements.
Qualification and Experience Requirements:
1. Bachelor’s degree or above in analytical chemistry, biochemistry, pharmacy, mass spectrometry, etc. Laboratory experience is preferred.
2. Experienced in using any triple quadrupole mass spectrometers of Waters, AB, and Agilent; Waters is preferred.
3. Familiar with or possess an understanding of the medical device industry regulations. Familiar with IVD is preferred.
4. Practical and meticulous at work, possess independent thinking and strong execution abilities, professionalism, and strong learning ability.
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