岗位职责:

1、 负责带领团队完成新药CDMO业务及原料药新产品开发工作；

2、 负责在研项目技术质量把控，指导研发人员解决研发过程中的关键技术问题，形成技术突破、创新应用和专利申报；

3、 负责协调公司内外资源，确保部门按时限、高质量完成研发项目；

4、 负责立项评估、项目风险评估、技术评审、专利布局等研发决策工作参与公司研发战略制定；

5、 熟悉分析中各类分析方法的理论基础，有实战经验，能够与注册及质量研究部门进行交流、协调；

6、 根据公司项目发展规划制定部门年度研发计划及预算管控，负责部门专业管理制度与流程建设；

7、 根据公司发展重点培养专业技能人才，形成阶梯人才培养队伍，为公司长远发展培养队伍；

8、 完成上级安排的其他任务。

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.

任职要求:

1、药学、化学等与有机合成相关专业，博士优先；

2、5 年以上新药或仿制药研发经验，有成功的技术转移及商业化经验，扎实的化学合成及分析功底；

3、熟悉国内外药品注册、研发的流程及ICH法规，有DMF 备案经验者优先；熟悉QbD，专利挑战等领域知识；

4、掌握相关专业技能，有多个项目研发成功经验，至少管理过10人及以上团队。

5、具备较强的沟通， 领导及管理的能力，以及优秀的职业精神和团队合作精神。

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.