上海招聘

工作职责:

1. Lead the efforts for impurity analytical development studies within ASU department; function as project leader role in analytical development projects.

2. Plan and execute impurity research for both drug substances and drug product including but not limited to genotoxic impurity, residual solvents, heavy metal determination, forced degradation study, unknown impurity isolation and identification, and impurity synthesis & analysis.

3. Review and coordinate team project plan and work schedule; summarize and analyze project management related data to provide guidance for future team work

4. Communicate with client independently through emails and participate the teleconference with the client, about study design and requirements.

5. Communicate with different groups or cross function team for the project co-ordination and management.

6. Review and/or approve formal documents related to R&D and GMP activities, including but not limited to analytical method, validation report, R&D report, stability report, quality specification, test report, data summarization, etc.

7. Responsible for laboratory daily supervision and management, and cooperate with other group and department to establish and improve laboratory operation mechanism

任职资格:

1. Ph.D. or M.S. degree in pharmaceutical science, pharmaceutical analysis, analytical/physical chemistry, pharmaceutical chemistry or other directly-related science disciplines.

2. Familiar with MS technical, Pharmaceutical synthesis, toxicology, structure identification techniques, experienced with impurity related analytical techniques is desirable.

3. Skillful at different regulations related impurity research such as ICH Q3, ICH M7, FDA, EMEA and CFDA related guideline.

4. Strong technical expertise in impurity control analytical development of analytical chemistry and pharmaceutical, 8 years for M.S. and 5 years for Ph.D.

5. More than 2 year projects and team management experience.

6. Must be experienced with standard analytical techniques, particularly LC-MSn, GC- MSn, ToF-MS, etc.

7. Must be able to work in a team-oriented manner in order to accomplish performance objectives.

8. Must have supervisory experience in a pharmaceutical R&D environment in both project and people management.

9. Outstanding communication，both written and verbal, skills in English. Good interpersonal communication skills.

合全（sta）是药明康德全资子公司，其中包括：上海合全药物研发有限公司( 原药明康德工艺研发部，上海外高桥)，合全药物公司是sta 专门从事工艺合成路线研发及放大实验的研发团队；合全药业金山公司和常州公司是sta 提供符合cgmp 标准的中式放大及商业化生产的基地。
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.