崗位職責(zé):
1、 負(fù)責(zé)帶領(lǐng)團(tuán)隊(duì)完成新藥CDMO業(yè)務(wù)及原料藥新產(chǎn)品開(kāi)發(fā)工作;
2、 負(fù)責(zé)在研項(xiàng)目技術(shù)質(zhì)量把控,指導(dǎo)研發(fā)人員解決研發(fā)過(guò)程中的關(guān)鍵技術(shù)問(wèn)題,形成技術(shù)突破、創(chuàng)新應(yīng)用和專(zhuān)利申報(bào);
3、 負(fù)責(zé)協(xié)調(diào)公司內(nèi)外資源,確保部門(mén)按時(shí)限、高質(zhì)量完成研發(fā)項(xiàng)目;
4、 負(fù)責(zé)立項(xiàng)評(píng)估、項(xiàng)目風(fēng)險(xiǎn)評(píng)估、技術(shù)評(píng)審、專(zhuān)利布局等研發(fā)決策工作參與公司研發(fā)戰(zhàn)略制定;
5、 熟悉分析中各類(lèi)分析方法的理論基礎(chǔ),有實(shí)戰(zhàn)經(jīng)驗(yàn),能夠與注冊(cè)及質(zhì)量研究部門(mén)進(jìn)行交流、協(xié)調(diào);
6、 根據(jù)公司項(xiàng)目發(fā)展規(guī)劃制定部門(mén)年度研發(fā)計(jì)劃及預(yù)算管控,負(fù)責(zé)部門(mén)專(zhuān)業(yè)管理制度與流程建設(shè);
7、 根據(jù)公司發(fā)展重點(diǎn)培養(yǎng)專(zhuān)業(yè)技能人才,形成階梯人才培養(yǎng)隊(duì)伍,為公司長(zhǎng)遠(yuǎn)發(fā)展培養(yǎng)隊(duì)伍;
8、 完成上級(jí)安排的其他任務(wù)。
operating duty:
1. Responsible for leading the team to complete the cdmo business of new drugs and the development of new API products;
2. Be responsible for controlling the technical quality of research projects, guiding R & D personnel to solve key technical problems in the R & D process, and forming technological breakthroughs, innovative applications and patent applications;
3. Coordinate internal and external resources of the company to ensure that the Department completes R & D projects with time limit and high quality;
4. Be responsible for R & D decisions such as project initiation evaluation, project risk assessment, technical review and patent layout, and participate in the formulation of the company
s R & D strategy;
5. Be familiar with the theoretical basis of various analysis methods in analysis, have practical experience, and be able to communicate and coordinate with registration and quality research departments;
6. Formulate the Department
s annual R & D plan and budget control according to the company
s project development plan, and be responsible for the construction of the Department
s professional management system and process;
7. According to the company
s development focus, cultivate professional and skilled talents, form a ladder talent training team, and train the team for the company
s long-term development;
8. Complete other tasks assigned by the superior.
任職要求:
1、藥學(xué)、化學(xué)等與有機(jī)合成相關(guān)專(zhuān)業(yè),博士?jī)?yōu)先;
2、5 年以上新藥或仿制藥研發(fā)經(jīng)驗(yàn),有成功的技術(shù)轉(zhuǎn)移及商業(yè)化經(jīng)驗(yàn),扎實(shí)的化學(xué)合成及分析功底;
3、熟悉國(guó)內(nèi)外藥品注冊(cè)、研發(fā)的流程及ICH法規(guī),有DMF 備案經(jīng)驗(yàn)者優(yōu)先;熟悉QbD,專(zhuān)利挑戰(zhàn)等領(lǐng)域知識(shí);
4、掌握相關(guān)專(zhuān)業(yè)技能,有多個(gè)項(xiàng)目研發(fā)成功經(jīng)驗(yàn),至少管理過(guò)10人及以上團(tuán)隊(duì)。
5、具備較強(qiáng)的溝通, 領(lǐng)導(dǎo)及管理的能力,以及優(yōu)秀的職業(yè)精神和團(tuán)隊(duì)合作精神。
Qualifications:
1. chemistry and organic synthesis, doctor is preferred;
2. At least 5 years experience in new drug or generic drug research and development, successful technology transfer and commercialization experience, solid chemical synthesis and analysis skills;
3. Familiar with domestic and foreign drug registration, R & D process and ICH regulations, DMF filing experience is preferred; Familiar with QBD, patent challenge and other fields;
4. Master relevant professional skills, have successful experience in R & D of multiple projects, and have managed a team of at least 10 people.
5. Strong communication, leadership and management skills, excellent professionalism and teamwork spirit.