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无工作经验 -
本科 -
招3人 -
03-06 发布
- 五险一金
- 免费班车
- 餐饮补贴
- 绩效奖金
- 定期体检
职位描述
Responsibilities:1. Plan and execute method development and validation for drug substance.2. Perform sample analyses including but not limited to samples for drug substance used forclinical trials and GMP drug substance to be released.3. Execute stability program for drug substance under cGMP where applicable.4. Characterize the primary and secondary reference standards for lab use within the companyand analytical development clients.5. Assume responsibility for assigned instruments, maintaining them in proper calibration andworking order according to the appropriate SOP.6. Write up formal analytical methods, method validation reports, stability study summary,Certificate of Analysis (CoA), method validation protocols and/or summaries/reports relatedto analytical research and development works.7. All work will be conducted in compliance with cGMP regulations when applicable.8. Be expected to perform the job independently with limited supervision from senior scientists,group leaders and senior management.9. Must be customer-oriented and able to show flexibility and ability to work with multipleprojects. Must be able to prioritize the workload to meet the pre-determined timelines.10. Individuals will be expected to accomplish their work assignments by interacting closelya) with fellow PDS scientists and by developing cooperative working relationships with otherpersonnel inside the company.11. Good communication, open exchange of information and project teamwork will be requiredin order to meet job performance. There must be strong recognition of high performancestandards and of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.Qualifications:1. Must have experience in analytical method development and validation as well as2. pharmaceutical analysis according to written method/protocols.3. Must be trained in or be familiar with the requirements of the FDA cGMP regulations, ICHguidelines as well as drug development process.4. BD and above degree in analytical chemistry, pharmaceutical analysis or other directlyrelatedscience discipline with experience or training in pharmaceutical analysis.5. Must be experienced with standard analytical techniques, particularly HPLC, GC. GC-MSLC-MS experience/familiarity with dissolution apparatus is desirable.6. Strong communication skills, both written and verbal, and outstanding interpersonal skills areessential job requirements.7. Must be able to work in a team-oriented manner in order to accomplish performanceobjectives. 职能类别： 药品生产/质量管理 质量管理/测试工程师(QA/QC工程师) 关键字： QC 质量 品质 医药 验证 分析 生物 理化
联系方式
外高桥保税区德林路90号
公司信息
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最高效的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.
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