Preformulation Group leader/Assistant director
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:2017-01-09
- 工作地点:上海-浦东新区
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:硕士
- 职位月薪:10000-20000/月
- 职位类别:医药技术研发人员
职位描述
职位描述:
Key accountabilities:
1. Lead the efforts for preformulation analytical development studies within ASU department; function as project leader role in analytical development projects.
2. Plan and execute preformulation studies for drug substances including but not limited to determination of salt selection screening, polymorph screening study, solubility of selected form, stability, powder property evaluation, excipient compatibility and study updates and reports.
3. Information retrieval, spectrum analysis and data summary, clearly define study purpose, timeline, tester role and resource.
4. Communicate with client independently through emails and participate the teleconference with the client, about study design and requirements.
5. Design and review stability program protocols, and develop, optimize, and enforce laboratory methods and SOPs.
6. Review and/or approve the formal analytical methods, method validation reports, stability study report, Report of Analysis (RoA), summaries/reports related to analytical research and development works.
7. Train team members with the basic analytical knowledge and technology skills and team management.
8. Project tracking, error handling, trouble shooting, results report out, study material archive and notebook management.
9. Perform daily management of the analytical labs; conduct the group training in technology and compliance as needed.
Requirements:
1. Ph.D. or M.S. degree in pharmaceutical science, pharmaceutical analysis, analytical/physical chemistry, physical pharmacy or other directly-related science disciplines.
2. Familiar with analytical techniques, experienced with solid-state characterization, analytical techniques is desirable.
3. Strong technical expertise in preformulation analytical development of analytical chemistry and pharmaceutical, 5 years for M.S. and 2 years for Ph.D.
4. More than 2 year projects and team management experience.
5. Must be experienced with standard analytical techniques, particularly HPLC, LC/MS, DSC, TGA, DVS, XRPD, etc.
6. Must be able to work in a team-oriented manner in order to accomplish performance objectives.
7. Must have supervisory experience in a pharmaceutical R&D environment in both project and people management.
8. Outstanding communication,both written and verbal, skills in English. Good interpersonal communication skills.
举报
分享
Key accountabilities:
1. Lead the efforts for preformulation analytical development studies within ASU department; function as project leader role in analytical development projects.
2. Plan and execute preformulation studies for drug substances including but not limited to determination of salt selection screening, polymorph screening study, solubility of selected form, stability, powder property evaluation, excipient compatibility and study updates and reports.
3. Information retrieval, spectrum analysis and data summary, clearly define study purpose, timeline, tester role and resource.
4. Communicate with client independently through emails and participate the teleconference with the client, about study design and requirements.
5. Design and review stability program protocols, and develop, optimize, and enforce laboratory methods and SOPs.
6. Review and/or approve the formal analytical methods, method validation reports, stability study report, Report of Analysis (RoA), summaries/reports related to analytical research and development works.
7. Train team members with the basic analytical knowledge and technology skills and team management.
8. Project tracking, error handling, trouble shooting, results report out, study material archive and notebook management.
9. Perform daily management of the analytical labs; conduct the group training in technology and compliance as needed.
Requirements:
1. Ph.D. or M.S. degree in pharmaceutical science, pharmaceutical analysis, analytical/physical chemistry, physical pharmacy or other directly-related science disciplines.
2. Familiar with analytical techniques, experienced with solid-state characterization, analytical techniques is desirable.
3. Strong technical expertise in preformulation analytical development of analytical chemistry and pharmaceutical, 5 years for M.S. and 2 years for Ph.D.
4. More than 2 year projects and team management experience.
5. Must be experienced with standard analytical techniques, particularly HPLC, LC/MS, DSC, TGA, DVS, XRPD, etc.
6. Must be able to work in a team-oriented manner in order to accomplish performance objectives.
7. Must have supervisory experience in a pharmaceutical R&D environment in both project and people management.
8. Outstanding communication,both written and verbal, skills in English. Good interpersonal communication skills.
职能类别: 医药技术研发人员
关键字: 处方前分析 组长 助理主任 分析 制剂
公司介绍
药明康德是国际领先的开放式能力与技术平台公司,为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任,以客户为中心的宗旨,药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等,正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目,致力于将最新和***的医药和健康产品带给全球病患,实现“让天下没有难做的药,难治的病”的梦想。
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