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杏國新藥股份有限公司 - CMC專員

http://bit.ly/1TmJrs4

工作說明：

Responsibilities include but not limited to:

1.Document Preparation

-Author/ co-author and review reports, SOPs, and CMC documentation.

2.Communication

-Support and maintain effective communication with CMO, RD, process development, formulation, QAC, PM, legal, IP and clinical group.

-Take part or lead external and internal collaboration projects.

3.Cost Considerations

Work with company management to develop and evaluate budget submission at the beginning of any CMO project.

4.Process Technology

-Technology and scale-up support to the clinical manufacturing in Pilot Plant (Future), External CMOs and Pack & Label activities to provide drug product for use in global or local clinical trials.

-Thoroughly analyze the production results and process, solve production problems, optimize the parameters of key equipment and process troubleshoot.

-Survey new technologies and relative equipment vendors.

5.Technology Transfer

-Perform process qualification/validation and participate in technology transfer activities.

-Sorting the CMC-related documents/raw data from licensors

-Involve turnkey project for licensees.

6.Others

-Take charge of the assigned matters.

7.Training

-Prepare scientific presentations or training.

工作地點：

台北市信義區 東興路69號4樓

工作時間：

日班說明：日班，08:30~17:30

休假制度：

週休二日

是否出差：

需出差

工作性質：

全職

職務類別：

醫藥研發人員、生物科技研發人員、品管／品保主管

工作待遇：

面議

需求人數：

1人

到職日期：

急徵

職缺更新：

2015/12/29

求才條件

身份類別：

一般求職者

學歷限制：

碩士 以上畢業

科系限制：

藥學學類, 生物學類, 醫藥工程學類, 化學學類

工作經驗：

4年以上工作經驗

語言能力：

英文 聽:精通 說:精通 讀:精通 寫:精通

電腦專長：

Word、Excel、PowerPoint、Outlook、Project

附加條件：

1.At least master degree in analytical chemistry, biochemistry, chemical engineering, pharmacy or relative fields.

2.At least 4 years CMC working experiences in pharmaceutical industries

(Ph.D. degreed with 0-2 years of post-doctoral experience or Master degree with a minimum of 4 years of relevant experience in pharmaceutical, biopharmaceutical, and/or vaccine development.)Industry experience is highly preferred, but fresh graduates will be considered as well.

3.Fluent in Chinese and English (Germany or Japanese is plus)

4.A thorough understanding of pharmaceutical process/manufacturing technologies.

5.Ability to work effectively with cross-functional groups.

6.Ability to prepare technical reports and presentations.

7.Understanding of GMP requirements and other FDA regulatory requirements associated with CMC is desired.

8.Experience in processing of powders or liquids is plus.

9.Familiar with lyophilization or spray drying technology.

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