崗位職責:
1、 負責帶領團隊完成新藥CDMO業務及原料藥新產品開發工作;
2、 負責在研項目技術質量把控,指導研發人員解決研發過程中的關鍵技術問題,形成技術突破、創新應用和專利申報;
3、 負責協調公司內外資源,確保部門按時限、高質量完成研發項目;
4、 負責立項評估、項目風險評估、技術評審、專利布局等研發決策工作參與公司研發戰略制定;
5、 熟悉分析中各類分析方法的理論基礎,有實戰經驗,能夠與注冊及質量研究部門進行交流、協調;
6、 根據公司項目發展規劃制定部門年度研發計劃及預算管控,負責部門專業管理制度與流程建設;
7、 根據公司發展重點培養專業技能人才,形成階梯人才培養隊伍,為公司長遠發展培養隊伍;
8、 完成上級安排的其他任務。
operating duty:
1. Responsible for leading the team to complete the cdmo business of new drugs and the development of new API products;
2. Be responsible for controlling the technical quality of research projects, guiding R & D personnel to solve key technical problems in the R & D process, and forming technological breakthroughs, innovative applications and patent applications;
3. Coordinate internal and external resources of the company to ensure that the Department completes R & D projects with time limit and high quality;
4. Be responsible for R & D decisions such as project initiation evaluation, project risk assessment, technical review and patent layout, and participate in the formulation of the company
s R & D strategy;
5. Be familiar with the theoretical basis of various analysis methods in analysis, have practical experience, and be able to communicate and coordinate with registration and quality research departments;
6. Formulate the Department
s annual R & D plan and budget control according to the company
s project development plan, and be responsible for the construction of the Department
s professional management system and process;
7. According to the company
s development focus, cultivate professional and skilled talents, form a ladder talent training team, and train the team for the company
s long-term development;
8. Complete other tasks assigned by the superior.
任職要求:
1、藥學、化學等與有機合成相關專業,博士優先;
2、5 年以上新藥或仿制藥研發經驗,有成功的技術轉移及商業化經驗,扎實的化學合成及分析功底;
3、熟悉國內外藥品注冊、研發的流程及ICH法規,有DMF 備案經驗者優先;熟悉QbD,專利挑戰等領域知識;
4、掌握相關專業技能,有多個項目研發成功經驗,至少管理過10人及以上團隊。
5、具備較強的溝通, 領導及管理的能力,以及優秀的職業精神和團隊合作精神。
Qualifications:
1. chemistry and organic synthesis, doctor is preferred;
2. At least 5 years experience in new drug or generic drug research and development, successful technology transfer and commercialization experience, solid chemical synthesis and analysis skills;
3. Familiar with domestic and foreign drug registration, R & D process and ICH regulations, DMF filing experience is preferred; Familiar with QBD, patent challenge and other fields;
4. Master relevant professional skills, have successful experience in R & D of multiple projects, and have managed a team of at least 10 people.
5. Strong communication, leadership and management skills, excellent professionalism and teamwork spirit.