分析主管（总监）(J12145)

该职位来源于猎聘 职责描述： 1.作为分析项目管理主管，负责化学大分子项目分析管理工作。协助上级领导管理化学大分子CMC项目（如寡核苷酸，多肽，毒素连接子）从临床早期到后期阶段的顺利进行，并保证项目分析工作的进度与质量。 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. 2.参与并推动项目分析方法开发/确认/验证/转移方案和计划的制定和执行，相关的项目管理指导和培训，保证项目顺利开展。 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.负责参与并撰写分析工作报价和与客户进行技术沟通，同工艺部门协作及时完成报价工作。Prepare analytical service quotations and conduct technical discussions with clients, coordinating with process development teams for timely proposal submission. 4.与公司职能团队，包括AC, QC，工艺开发，业务开发，报价组紧密沟通，以有效执行所有合同项目，并跟进和保障项目及时交付。 Collaborate cross-functionally with AC, QC, Process Development, Business Development, and Quotation teams to ensure project execution and on-time delivery. 5.跨职能部门协作，确保符合NMPA和FDA的相关规定，支持并顺利完成IND/NDA申请的提交。 Coordinate with regulatory functions to maintain NMPA/FDA compliance, supporting successful IND/NDA submissions. 任职要求： 1.博士学历，4年以上创新药CMC经验，或者硕士学历，8年以上创新药CMC经验，寡核苷酸/多肽/或ADC分析相 关研究方向优先。 PhDdegree,withatleastfiveyearsCMCexperienceininnovativedrug，ormasterdegree,8yearsCMC experience，Oligonucleotide/peptide/ADCanalyticalispreferred. 2.对分析化学有深入的经验和知识。具有IND/NDA化学药和生物药申报的经验(NMPA,FDA)。 Indepthexperienceandknowledgeofanalyticalchemistry.ExperiencewithIND/NDAfilingapplicationsof chemicalandbiologicsdrugproducts(NMPA,FDA).