职位描述
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 spir**.
公司介绍
上海泓博智源医药股份有限公司(简称:泓博医药 股票代码:301230.SZ )是一家快速发展的新药研发服务及仿制药工艺创新研究与生产企业。自2007年12月成立以来,公司以科技创新为驱动力,以创建具有特色的“智力型”企业为目标,积极与客户及商业伙伴开展全方位的合作。
泓博医药总部坐落于上海浦东新区张江高科技产业园东区,拥有7800平方米的办公区、实验室及先进的仪器设备。公司自创立之初就着力为员工创造一个安全、舒适、科学的工作环境,目前拥有HPLC、chiral-HPLC、LC-MS、LC-MS/MS (API 4000)、IR、UV、GC、GC-MS、正/反相制备色谱、微波合成仪、平行合成仪等各类实验及检测设备。正是这样高品质的科研环境保证了泓博医药高质量的运营及科研成果。
泓博医药注重打造“科学为主、不断创新”的企业文化,并且将其渗透到公司的管理制度、人才培养、团队建设等各个方面。除注重科学及实验操作能力的培养之外,公司每年组织年会、素质拓展培训、生日会、及各种文体活动,同时还设立了团队建设专项基金。这些活动不仅为员工提供了纵向、横向的交流机会,同时增强了员工的归属感与团队合作意识。