I. Job Responsibilities:
1. In line with the company’s R&D strategy, conduct research, project initiation, design and development, and technical solution planning for new fluorescent quantitative PCR assay reagent products.
2. Record, organize, and analyze R&D data to ensure the completeness of all documentation; prepare product process and technical specifications; perform product performance evaluation and optimization; and manage clinical trials.
3. Participate in the daily management of the R&D center and assist with project submissions; collaborate with quality, production, and regulatory teams to complete product registration and manufacturing; provide technical support to the marketing department.
4. Draft product initiation documents, secure internal approval, and ensure timely completion of product initiation, R&D, translation, registration, and related tasks.
5. Conduct market research and compile updates and summaries on relevant topics (market trends, clinical guidelines, standards, competitors’ products, patents, and literature), acting as a product manager.
6. Oversee product design and development, maintain detailed records of R&D and registration-related experiments, produce required documentation, and draft or revise quality management system documents pertinent to the project.
7. Prepare technical documentation for product registration, ensuring compliance with applicable regulations and standards; coordinate with other departments to complete product filing and registration processes.
8. Provide technical support to other departments as needed.
9. Supply relevant research materials on the product and its technology, and participate in project submission activities.
10. Regularly organize knowledge-sharing sessions or training on product- and technology-related topics.
11. Assist the platform manager in overseeing daily laboratory operations, develop standard operating procedures (SOPs) for experimental protocols, and assume specific responsibilities (e.g., equipment and reagent management) to ensure safe and orderly lab operations.
12. Lead, mentor, and evaluate R&D assistants.
13. Complete ad hoc tasks assigned by management.
II. Qualifications:
1. Master’s degree or higher, with expertise in biochemistry, bioengineering, molecular biology, cell biology, genetic engineering, or related fields.
2. At least 2 years of work experience, preferably in the development of fluorescent quantitative PCR assay reagents.
3. Candidates with training in PCR assays, nucleic acid mass spectrometry, product development, or product registration are preferred.
4. Possess in-depth knowledge of the product’s market landscape, technical aspects, competitive offerings, and industry standards, enabling effective product management.
5. Proficient in molecular diagnostic IVD product development techniques; familiar with molecular and cellular biology principles and methodologies; knowledgeable about disease diagnosis and treatment pathways, medical devices, and in vitro diagnostic reagents.
6. Skilled in conducting experiments relevant to the assigned technical platform; capable of independently designing experimental protocols and actively acquiring knowledge from other platforms.
7. Familiar with the filing and registration procedures for medical devices, as well as applicable regulations and standards.