美国药典诚聘实验室分析员（方法开发验证）

Position Title Scientist III / IV, Excipient

Job Type:  Full-Time 

Reports To: Director, Medicine Compendium

Location:  Zhangjiang Hi-Tech Park, Pudong, Shanghai 

Post Date:  25/06/2013 

 

Function of the Position:

 

As a member of the Analytical Sciences group, the successful candidate will play a leading role on new and ongoing analytical proceduredevelopment for USP Medicine Compendiumprograms.

Interpret observations/results, and present data in scientific meeting /management meeting internally/externally.

 

 

 

Roles and Responsibilities:

 

·           Lead analytical proceduredevelopment for characterizationandtesting of drug substances,excipients anddrug product. Conductanalytical procedurevalidation according to pre-approvedprotocol.

 

·           Provide technical expertise in planning, monitoring, and maintaining project timelines to meet business needs.

 

·           Present the results of your work internally and externally, and write reports that will be submitted to USP expert committee. Conduct all activities in compliance with established regulatory requirements. Assist in the development of protocols to conduct studies in conjunction with others to meet requirements.

 

·           Understand and complywith Safety, Good Laboratory Practice/Good ManufacturePractices (GLP/GMP), and Standard Operating Procedures(SOP)and Policies.

 

·           Record, evaluate, interpret and summarize technical data. Develop and validate calculation procedures. Document activities in technical notebooks or validated approved electronic media. Design experiments and preparereports, memosor documents with little direct guidance.

 

·           Maximize innovation by utilizing original concepts and creative thinking.

 

·           Can shift priorities and projects as organizationneeds change. As needed, assist others as priorities change. Observe safety rules and works safely in the laboratory.

 

·           Plan and track analytical development objectives, timelines, priorities, and resources

 

·           Mentorship and management of internal analytical scientists.

 

 

 

Frequent Contacts:

 

 USP scientific liaison

 

 Reference Standards Evaluation Staff

 

 Documentary Standards Division Staff

 

 Quality Assurance Staff

 

 Applied Compendial Research Division Staff

 

 

 

Minimum Requirements:

 

Ph.D.with at least 2 years in chemistry, analytical chemistry,pharmacy or related field.

 

Master degree with at least 5 years of relevant experiences.

 

 

 

Knowledge, Skills, Abilities, Training and Experience Requirements:

 

 Practical knowledge of chemical principles, theories, and practices, and a working knowledge of common analytical procedures, including skill in calibrating and operating analytical instruments such as spectrophotometers and chromatography equipment. Experience in pharmaceutical and/or biotechnology industry preferred.

 

 Takes personal responsibility to ensure work is delivered on time and is the highest possible quality.

 

 Strong communication and presentation skills, both verbal and written in English.

 

 Strong chromatography knowledge with depth of practical experience on analytical techniques such as HPLC, LC-MS, IC, and GC, GC-MS Experience in xcipient analysis is highly preferred.

 

 A good knowledge of GLP/cGMP regulations , ICH/VICH guidelines, and compendial methods. Incumbent must possess detailed knowledge of separation sciences and modern analytical instruments, and must be able to work with others to accomplish project goals.

 

 Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment. 

 

 

关于：美国药典

 

除美国之外，USP标准和标准品在的世界上其他130多个国家也得到广泛的使用。建立185年以来，这些标准一直服务于世界各地，确保公众获得优质的药品。

鉴于中国和亚太地区其他国家的战略重要性，USP在上海张江高科技园区设立了中华区总部，并建成了USP在全球的第三个标准品研发中心实验室。现公开招聘所述职位，诚邀您的加盟。

应聘者请将中英文简历、近照、应聘职位和期望薪资发送给我们。

欲了解USP更多详情，欢迎访问我们的网站。

The United States Pharmacopoeia(USP)is the official standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States.USP is also a world leader and its reference standards are recognized and used in many other countries outside the United States. These standards have been helping to ensure good pharmaceutical care for people throughout the world for more than 185 years.

For more details about USP, please visit our website.

Attaching great importance to China and Asian Pacific countries, USP is setting up its regional headquarter in Shanghai located in Zhang Jiang Hi-Tech Park.

Currently we are looking for the positions for USP-China.Please indicate the position that you are interested and send us your resume and salary expectation to us.

Please send your bilingual resume to us

请将中英文简历发至所述邮箱：uspchinahr@usp.org。