越洋医药开发有限公司岗位描述
Job De****ion for Overseas Pharmaceutical Ltd.
研发总监/研发副总 Director/VP
资质要求Professional Qualification
1. 博士或硕士学位,5年以上药物研发工作经验。
Ph.D. or Master degree with five years and above industry experience.
2. 有产品开发的成功先例,包括申报资料撰写和突破专利技术。
Successful experiences with solid oral dosage form product development for China CFDA and US FDA including ANDA, IND-NDA filing, formulation technology development to go around patents.
3. 熟悉制剂新技术包括缓控释技术和难溶药物增溶技术等。
Familiar with advanced/novel formulation technologies in modified release and solubility/bioavailability enhancement.
4. 熟悉与制剂技术相关的仪器设备的原理及操作并有很强的动手能力。
Familiar with principle/mechanism for formulation related apparatus/equipment with strong hands-on experience.
5. 拥有管理团队和项目的经验。
Experience with team and project management.
6. 从技术和注册两个方面熟悉产品开发流程。
Familiar with product development process from technical and regulatory perspectives.
7. 对制剂新技术及新产品开发有强烈的兴趣和热情。
Strong enthusiasm about advanced/novel technologies as well as new product development.
8.具有良好的沟通能力、团队合作精神及领导技能。
Excellent communication, team work and leadership skills.
9.具有同时管理多个项目并能按时完成设定目标的能力。
Capable of managing multiple projects and achieving approved ****ives.
10.具有很强的英语阅读,写作和口表达能力。
Strong capability in English reading, writing and oral communication.
11.用于国内外出差的时间可能达到 30%。
Willing to travel domestically and internationally up to 30%.
岗位职责及工作范围 Responsibilities and Scope of Work
1.产品开发 Product Development.
领导和管理一个研发团队应用制剂新技术(缓控释或微粒载药或难溶药物增溶等)进行新产品的开发包括立项,配方工艺研发、放大、注册及产业化。
Lead and manage a team of scientists to apply advanced/novel technologies including solid oral modified release and solubility/bioavailability enhancement technologies for product development. The process will involve new product development proposal, formula and process development/optimization, scale-up, regulatory filling and commercial manufacture.
为新产品开发评估第三方的制剂技术。
****uate third party formulation/drug delivery technologies in new product development.
领导团队与国内和国际的合作伙伴进行新产品开发或接受技术转让。
Lead the team to collaborate with domestic and international partners for product development or for technology transfer.
2.技术平台的开发和建设 Platform Technology Development
领导团队制订出制剂新技术平台建设计划并付诸实施.这些技术包括缓控释或微粒载药或难溶药物增溶等。
Lead the team to propose plans for platform technology development and implement the approved plans. These platform technologies include modified release and solubility/bioavailability enhancement technologies.
撰写研究论文并在国内及国际的学术期刊上发表,在国内和国际会议上进行海报展出和会议演讲。
Write research papers and publish them in domestic and international peer reviewed journals. **** and podium presentations at domestic and international conferences/seminars/workshops/symposiums.
撰写与新技术相关的专利文件。
Write and file new technology related patents.
3.管理 Management
研发人员的招聘。
Hire team members.
管理团队成员和项目。
Manage/supervise team members and projects.
评估团队成员,提出晋升和降职建议。
****uate team members and propose promotion and demotion.
为新研发人员提供技术培训及流程培训。
Provide trainings for research scientists including technical training and working process training.
泰州越洋医药开发有限公司成立于2011年12月,坐落于江苏省泰州市中国医药城国家新药创制基地。公司由海归团队创建,致力于应用具有自主知识产权的缓控释平台技术开发原创制剂(世界首创)新药。
公司本着“市场为导向,人才为灵魂,疗效为目标,技术为核心”的经营理念,采用“轻资产,重技术”的经营策略,产品定位中美市场,采用中国本土生产的产品“越洋”销售和技术销售相结合的盈利方式,实现中国本土生产的高端制剂产品“越洋”销售至美国,实现中国由原料药出口向制剂产品出口转型升级,实现高端制剂国产化,高额利润本土化。为患者提供疗效更好,安全性更高,使用更方便的药物。