上海招聘

工作职责:

Stability Management:

1.1 Establish/review stability test protocol in compliance with ICH guidelines and as per client request. Establish the template for stability protocols for different clients.

1.2 Maintain the Lab Sample Manager System.

1.3 Maintain the stability project tracker and stability sample inventory.

1.4 Prepare/review the sample plan weekly.

1.5 Prepare the list projects that have completed or terminated monthly and follow-up the sample processing.

1.6 Monitor the temperature and humidity for stability chambers and stability rooms, give quick response for the urgency situation.

1.7 Troubleshooting of issues occurred during the daily work.

2. GMP/GLP requirements, Safety, Healthy and Environment:

Follow GMP/GLP requirements, relevant company SOPs and HSE regulations; instruct and monitor HSE activities within the lab area; Follow 5S guideline, and maintain good housekeeping in lab areas.

3. Audits:

Coordinate and participate in preparation of documents for inter audits and client audits.

4. Personnel Development:

4.1 Initiate training and education program for staff according to their needs.

4.2 Assist the leader to build up the team.

任职资格:

Education: BS, MS or Ph.D. degree in analytical chemistry, pharmaceutical analysis, food science or other directly-related science discipline with experience or training in analytical chemistry, instrument analytical science, pharmaceutical analysis or equivalent experience.

2. Work experience: At least experience in chemical, pharmaceutical, GMP lab background or analytical method development, have training record about compound and drug product management.

3. Technical and professional knowledge:

3.1 Must be trained in or be familiar with the requirements of the FDA cGMP/GLP regulations, ICH guidelines as well as drug development process.

3.2 Skilled operation LIMS and familiar with the system maintenance.

3.3 Skilled operation for T/H, Flashlink data logger and report print out. Skilled operation the SENSATRONICS Temperature and Humidity Monitoring System.

3.4 Skilled operation of stability instruments, such as chambers and refrigerator, stability rooms etc with corresponding monitoring software.

4. Others:

4.1 Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements. There must be strong recognition of high performance standards and of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.

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

4.3 Must be customer-oriented and able to show flexibility and ability to work with multiple projects. Must be able to prioritize the workload to meet the pre-determined timelines.

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.