職位描述：
Key accountabilities:
1. Lead the efforts for analytical development studies within ARD department; function as project leader role in analytical development projects.
2. Plan and execute analytical method development and validation for drug substances/drug products; perform sample analyses including but not limited to samples for drug substances /drug products used for clinical trials;
3. Plan, Coordinate, and oversee the work activities of scientific staff within the assigned group.
4. Be responsible for project management starting from project execution/project following up, regular analytical development update, review and approval of analytical protocols/reports. Assist the interaction with partners by issuing project reports, entertaining on-site visitation and through tele-, web- or video-conferencing etc.
5.Be responsible for improving the operation efficiency and productivity while ensuring the current quality systems in full compliance to all applicable regulatory standards
6.Perform daily management of the analytical labs; conduct the group training in technology and compliance as needed.
Requirements:
1. Ph.D. or Master degree in analytical chemistry, pharmaceutical analysis or other directly-related science discipline with experience or training in analytical chemistry, pharmaceutical analysis or equivalent experience.
2. Very strong independent analysis of daily work and research capabilities, especially experience in DNA analysis method, high throughput analysis, separation methods, biological macro-molecules analysis.
3. Love analysis work, willing to innovate. Be good at solving problems from internal and external demand.
4. Strong communication skills, both written and verbal, especially in English，and outstanding interpersonal skills are essential job requirements.
崗位職責(zé)：
1、 領(lǐng)導(dǎo)研發(fā)部門的分析開發(fā)工作，作為項(xiàng)目負(fù)責(zé)人，負(fù)責(zé)相應(yīng)分析項(xiàng)目。
2、計(jì)劃和執(zhí)行藥物或化合物的分析方法開發(fā)和驗(yàn)證；進(jìn)行樣品分析，包括但不限于用于臨床試驗(yàn)的樣品；
3、計(jì)劃、協(xié)調(diào)和監(jiān)督組內(nèi)的分析人員的工作。
4、負(fù)責(zé)項(xiàng)目管理從項(xiàng)目執(zhí)行到項(xiàng)目跟進(jìn)，定期分析方法開發(fā)的更新，分析協(xié)議或報(bào)告的審查和批準(zhǔn)。通過現(xiàn)場(chǎng)訪問、遠(yuǎn)程，網(wǎng)絡(luò)或視頻會(huì)議等協(xié)助溝通與合作伙伴的合作
5、負(fù)責(zé)提高分析質(zhì)量和分析效率，同時(shí)確保目前的質(zhì)量體系完全符合所有適用的監(jiān)管標(biāo)準(zhǔn)
6、對(duì)分析實(shí)驗(yàn)室進(jìn)行日常管理；根據(jù)需要進(jìn)行技術(shù)培訓(xùn)和合規(guī)培訓(xùn)。
任職要求：
1、分析化學(xué)、藥物分析或其他直接相關(guān)學(xué)科的博士或同等經(jīng)驗(yàn)碩士學(xué)位，有分析化學(xué)、藥物分析等相關(guān)經(jīng)驗(yàn)。
2、非常強(qiáng)的獨(dú)立分析日常工作和研究能力，特別是在DNA分析方法、高通量分析分離方法、生物大分子分析等方面的經(jīng)驗(yàn)。
3、熱愛分析工作，愿意創(chuàng)新。善于從內(nèi)部和外部的需求中解決問題。
4、優(yōu)秀的人際交往能力，良好的英語書面和口語溝通能力。
