Work Location:Qingdao,China
Responsibilities:
1.Fully responsible for the management of the company's R&D laboratory and R&D system
(1) New drug declaration work, organizing pre-clinical research (pharmaceutical research, pharmacology and pharmacodynamics research) and registration declaration work, obtaining clinical approval documents that can start feasible and scientific clinical trials, organizing clinical research and registration declaration work, and obtaining Registration approval document;
(2) Functional food and health food research and development work, organize project feasibility research for new products, small test, pilot test, commercial batch process verification and production approval work, etc., to realize the industrial production of functional food and health food;
(3) Continuous improvement of product production process, organize production process optimization, organize strain screening, fermentation, drying, preparation and other process research to improve product quality and save production costs;
(4) Strain work. Organize selection and breeding of new strain with specific function,and reserve strain resources for the follow-up development of drugs, health food, and functional food.
2.Formulate annual R&D plans, organize implementation and control project progress, and complete annual R&D tasks;
3.Write the R&D project implementation plan, control key project nodes, evaluate technical bottlenecks and propose solutions, and reduce project development risks;
4.Guide and solve major key technical problems in the process of research and development and in the process of production transformation;
5.Responsible for project declaration, review of original records and CTD data;
6.Responsible for the daily management of the R&D laboratory and the construction and training of the team;
7.Responsible for the government's scientific and technological project declaration and organization of research and development, acceptance and other work.
Qualifications:
1.Master degree or above, major in pharmacy, more than 8 years of drug research and development work experience, at least 2 years of technical research and development team management experience;
2. Familiar with the whole process of drug research and development, registration and application, familiar with the requirements of national drug technology review, and have successful experience in new drug research and development in the fields of diabetes, tumor, immunity, inflammation, etc.;
3. Be able to assist the general manager to formulate the R&D strategy of the company (able to formulate 5-year and 10-year R&D strategic plans);
4. Have good English reading and writing skills, and be able to independently consult and translate relevant literature;
5. Strong sense of responsibility, good communication and team management skills.