崗位職責(zé):
1.作為分析項目管理主管,負(fù)責(zé)化學(xué)大分子項目分析管理工作。協(xié)助上級領(lǐng)導(dǎo)管理化學(xué)大分子CMC項目(如寡核苷酸,多肽,毒素連接子)從臨床早期到后期階段的順利進(jìn)行,并保證項目分析工作的進(jìn)度與質(zhì)量。
Act as the project manager with responsibility for analytical management of chemical macromolecule projects (such as oligonucleotides, peptides, payload linker). Assist senior leader in managing CMC projects from early to later phase, and ensured project progress and quality.
2.參與并推動項目分析方法開發(fā)/確認(rèn)/驗證/轉(zhuǎn)移方案和計劃的制定和執(zhí)行,相關(guān)的項目管理指導(dǎo)和培訓(xùn),保證項目順利開展。
Drive execution of analytical method development/qualification/validation/ transfer protocols for projects, providing relevant project management guidance and training, to ensure the smooth implementation of the project.
3.負(fù)責(zé)參與并撰寫分析工作報價和與客戶進(jìn)行技術(shù)溝通,同工藝部門協(xié)作及時完成報價工作。
Prepare analytical service quotations and conduct technical discussions with clients, coordinating with process development teams for timely proposal submission.
4.與公司職能團(tuán)隊,包括AC, QC,工藝開發(fā),業(yè)務(wù)開發(fā),報價組緊密溝通,以有效執(zhí)行所有合同項目,并跟進(jìn)和保障項目及時交付。
Collaborate cross-functionally with AC, QC, Process Development, Business Development, and Quotation teams to ensure project execution and on-time delivery.
5.跨職能部門協(xié)作,確保符合NMPA和FDA的相關(guān)規(guī)定,支持并順利完成IND/NDA申請的提交。
Coordinate with regulatory functions to maintain NMPA/FDA compliance, supporting successful IND/NDA submissions.
任職要求:
1.博士學(xué)歷,4年以上創(chuàng)新藥CMC經(jīng)驗,或者碩士學(xué)歷,8年以上創(chuàng)新藥CMC經(jīng)驗,寡核苷酸/多肽/或ADC分析相關(guān)研究方向優(yōu)先。
PhDdegree,withatleastfiveyearsCMCexperienceininnovativedrug,ormasterdegree,8yearsCMC
experience,Oligonucleotide/peptide/ADCanalyticalispreferred.
2.對分析化學(xué)有深入的經(jīng)驗和知識。具有IND/NDA化學(xué)藥和生物藥申報的經(jīng)驗(NMPA,FDA)。
Indepthexperienceandknowledgeofanalyticalchemistry.ExperiencewithIND/NDAfilingapplicationsof chemicalandbiologicsdrugproducts(NMPA,FDA).