职位描述

1.作为生物分析方法（如qPCR/ddPCR，流式细胞仪）开发和验证的专家，确保为支持的项目提供新开发和验证的方法 2.作为实验室技术主管。 （1）支持并负责临床前基因细胞治疗药物的检测设计和生物分析的技术指导工作，独立完成临床前基因细胞治疗药物的生物分析工作。 （2）具备选择、设计、开发和验证不同类型药物的qPCR/ddPCR/FACS等生物分析方法的能力，包括但不限于选择合适的生物分析方法，独立设计相关引物探针，筛选和优化引物探针/抗体，优化检测程序，方法开发和验证。 （3）明确实验室的基本操作流程，按照法规要求完成方法的开发和验证 （4）担任实验室主管，对实验室人员进行基因细胞治疗药物研发知识的培训，提供技术指导、支持和培训，确保实验室人员完成资格认证和后续的增殖培训。 （5）确保研究人员清楚地了解自己的职责并认可相关的标准操作程序。 （6）制定应急计划，应对影响时间和成果的突发事件，评估和记录任何偏离研究方案和/或标准操作程序对研究质量和完整性的影响，并在必要时采取适当的纠正措施。 （7）在研究过程中与质量保证人员进行有效沟通，并处理他们的发现。 （8）管理人力资源，包括筛选、面试和选拔新员工，为研究提供全面的免疫学团队支持。 3.对员工进行计划和定期培训，确保为员工提供足够的培训以执行所需的工作任务。 1.Serve as the expert in the development and validation of bioanalytical methods such as qPCR/ddPCR, flow cytometry to ensure newly developed and validated method for supported projects 2.As laboratory technical supervisor: （1）Support and responsible for the assay design and technical guidance of bioanalysis of preclinical gene cell therapy drugs independently （2）Possess ability to select, design, develop and verify bioanalytical methods such as qPCR/ddPCR/FACS for different types of drugs, includes but not limited to select appropriate bioanalytical methods, design relevant primer probes independently, screening and optimization of primer probes/antibodies, optimization of the assay procedure, method development and validation （3）Basic operation procedures of laboratory are clearly defined, complete the method development and verification in accordance with regulatory requirements （4）Serve as laboratory supervisor, perform the training of gene cell therapy drug research and development knowledge to laboratory staff, provide technical guidance, support and training, ensure that the laboratory staff completed qualification certification and subsequent enrichment training （5）Ensure that study personnel understand clearly their responsibilities and acknowledge relevant standard operating procedures （6）Contingency plan is in place for unforeseen events that affects timeline and deliverables and the impact of any deviations from the study protocol and/or standard operating procedures on the quality and integrity of the study is assessed and recorded, and take appropriate corrective action if necessary （7）Communicate effectively with the quality assurance personnel and deal with their findings during the conduct of the study （8）Manage human resources, including screen, interviewing and selecting new hires to develop full capacity immunology team for study support 3.Plan and provide regular trainings to staff to ensure adequate training is provided to staff to execute the required work assignments.

任职要求

1.应届博士毕业生或硕士毕业生，在生物化学和分子生物学、细胞生物学、药学、免疫学方面有3年以上的工作经验。 2.有基因&细胞治疗药物的学术或工业研究经验，熟练掌握A A V药物、寡核苷酸药物（mRNA疫苗、ASO类）、外泌体、肿瘤病毒、CART、CRISPR技术等至少两个专业领域。 3.熟悉基因及细胞治疗产品的分析技术和检测方法，包括但不限于分子生物学，如qPCR、ddPCR、bDNA、细胞功能测定、流式细胞仪、免疫原性检测、ELISA技术等。 1.Fresh PhD graduates or Master\'s degree with more than 3 years of work experience in biochemistry and molecular biology, cell Biology, pharmacy, immunology 2.Academic or industrial research experience in gene&cell therapy drugs, with proficiency in at least two specialty areas in A A V drugs, oligonucleotide drugs (mRNA vaccines, ASO classes), exosomes, oncolytic viruses, CART, CRISPR technology, etc. 3.Familiar with analytical technologies and detection methods for the gene & cell therapy products, including but not limited to molecular biology such as qPCR, ddPCR, bDNA, cell function determination, flow cytometry, immunogenicity detection, ELISA technology, etc.

联系方式

上班地址：苏州，中国