制剂研发部 - Project Leader (职位编号:J13327)
上海合全药物研发有限公司
- 公司规模:500-1000人
- 公司性质:合资
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-11-26
- 工作地点:上海-浦东新区
- 招聘人数:2人
- 工作经验:无工作经验
- 学历要求:招2人
- 语言要求:不限
- 职位月薪:1.5-2万/月
- 职位类别:医药技术研发管理人员
职位描述
工作职责:
1. Work closely with line manager to meet project timelines, departmental goal, and customer requests to make sure on time and on quality delivery.
2. Lead at least 1 scientists and 1 key project to perform including but not limited to, formulation/process development, scale up and process optimization for Phase IIb/III, generic and LCM projects.
3. Apply QbD related mindset and methodology into formulation and process development, scale up and post approval process optimization for all projects.
4. Support scale up, technical transfer (site to site or R&D to site) and product control strategy translation to shop floor, making sure the developed formulation and manufacturing process are capable of continuously manufacturing high quality drug product at commercial manufacturing site.
5. Independently design experiments and conduct drug product development work with an awareness of state-of-the-art technology to support formulation and process development of drug product. Generate development plans, summaries and reports as needed.
6. Provide technical leadership to the group and project team for the rapid resolution of technical issues during process development, scale up, technical transfer and post approval commercial manufacturing.
7. Lead at least 2 scientists as project team to complete projects on time and on quality, including but not limited to: project planning and management, experiments and risk communication and management, related technical dossier documentation, internal and external cross functions facilitating, etc.
8. Mentor and coach junior scientists in designing and implementing innovative solutions for assigned activities.
任职资格:
1. Education 教育: Pharmaceutics or other directly-related discipline with 5+ years experience or training in formulation development as well as clinical product manufacturing.
2. Major 专业知识: Modern pharmaceutics theory esp. industrial pharmaceutics. Extensive experience in process development, process scale up, trouble shooting and process optimization of oral solid dosage form. Familiar with development process of new and generic drug product and relative regulations.
Know-how and expertise in lab scale, pilot scale and production scale pharmaceutical equipment for oral solid dosage form.
3. English: good written and oral communication skills in Mandarin and English.
4. Candidates with extensive experience in process development, process scale up, trouble shooting and process optimization of oral solid dosage form are desired.
职能类别:医药技术研发管理人员
公司介绍
shanghai syntheall pharmaceutical co., ltd. is a wholly-owned subsidiaries of wuxi app tec, including:
sta r&d is professional in route selection and process scaled up r&d;sta jinshan and changzhou are the pilot plants and commercial production base under cgmp.
sta 公司愿景 sta vision:
改变创新药api 的工艺研发和生产模式,加快新药研发速度,降低新药成本,造福人类健康。
transform how industry develops and manufactures apis, shorten the time and lower the cost of new drug developments, improve the quality of life.
sta 公司使命 sta mission:
不断创新、不断完善创新药api 的工艺研发以及研发和商业化生产的一体化平台,为全球新药研发机构提供最优质***效的api 工艺研发和生产一体化服务和***解决方案。
constantly enhance the capabilities of our fully-integrated api development and manufacturing platform from preclinical batches to commercial supplies, provide highly efficient and cost-effective solutions to our partners worldwide.
联系方式
- 公司地址:富特中路288号