Group Leader of Preformulation
上海药明康德新药开发有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2015-06-18
- 工作地点:上海-浦东新区
- 招聘人数:1
- 工作经验:一年以上
- 学历要求:博士
- 语言要求:英语熟练
- 职位类别:医药技术研发管理人员 医药技术研发人员
职位描述
Key accountabilities:
1. Lead the efforts for preformulation studies and analytical development within the formulation department; function as project manager role in preformulation development and analytical development projects.
2. Plan, manage and supervise all the scientific activities of preformulation group.
3. Review planning and execution of preformulation studies for drug substances including but not limited to determination of physicochemical properties and measurement of powder properties polymorph screening and salt form selection.
4. Review and amend work protocols, progress reports and final reports for preformulation projects handled for review and approval by customers.
5. Review planning and execution of support for formulations for toxicity studies by performing sample analyses ( assay, related substances, particle size determination, form change etc)
6. Lead and manage a group of preformulation scientists. Perform daily management of the preformulation and analytical labs; conduct the group training
Core business/Functional skills and education.
1.Ph.D. degree in pharmaceutical science, pharmaceutical analysis, physical chemistry/ physical pharmacy or other directly-related science discipline and at least two years related working experience in pharmaceutical industry.
2.Must be experienced with standard analytical techniques, particularly HPLC, GC. GC-MS LC-MS; experience/familiarity with dissolution apparatus and preformulation study instruments such as XPRD, laser particle size distribution, DSC, TGA is desirable.
3.Must have experience in preformulation area or analytical development as well as pharmaceutical analysis according to written method/protocols.
4.Must be trained in or be familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines as well as drug development process.
5.Must be able to work in a team-oriented manner in order to accomplish performance objectives.
6.Must have supervisory experience in a pharmaceutical R&D environment in both project and people management.
7.Strong communication skills, both written
公司介绍
联系方式
- Email:zhuyun@wuxiapptec.com
- 公司地址:江北新区华康路122号南京生物医药谷加速器四期07栋
- 电话:15738851478