1. Set up biological assays and complete biological analysis projects. 生物学分析方法建立与完成各分析任务 a) Setup antibody related biological analysis: affinity assay, specificity validation, cellular binding assay, endocytotic assay, antibody humanization, antibody expression, and so on. 熟悉抗体验证各生物学分析方法:亲和力、特异性验证、细胞系结合检测、内吞检测、人源化、抗体表达等 b) Setup ADC (including linker and payload) in vitro activity assays and safety evaluation assays, such as building target overexpression cell line, cellular cytotoxicity assay, bystander effect assay, PBMC activity assay, ADCC/ADCP/CDC activity assay, satbility assay. 建立ADC(含linker与payload)体外细胞活性与安全性评估方法,如靶标过表达细胞系建立、细胞杀伤分析、旁观效应、PBMC活性、ADCC/ADCP/CDC活性、稳定性评估等 c) cooperated with outside resource to complete ADC in vivo efficacy and safety evaluation. 建立或合作完成ADC动物药效模型分析,与预毒理安全性评估 d) manage the team to complete customers' or company R&D analysis projects 带领团队完成相应的分析任务 e) cooperate with CMC and IND teams to solve technical problems, and prepare the materials for IND. 配合CMC与IND团队完成必要的技术问题解决与申报材料准备; 2. Laboratory management 实验室管理 a) Be responsible for the drafting, release, upgrading and other work of SMP/SOP documents. 负责SMP/SOP文件起草、发布、升版等工作。 b) Ensure the relevant requirements of laboratory 5S management. 确保实验室5S管理的相关要求 3. Team building and management 团队建设及管理工作 a) Cooperate with recruitment work and complete team formation. 配合招聘工作,完成团队组建。 b) Regular team training on their professional skills 定期对团队成员的业务水平进行培训。 c) Regular summarization on the progressing in ADC 定期跟踪ADC或制药的进展,进行综述性评估与总结
2. More than 3 years of experience in biological analysis for antibody related drugs. Preferably with ADC, linker, and payload experience. Preferably experience on antibody discovery, antibody engineering, bispecific antibody. 3年以上抗体类药物生物学分析工作经验。有ADC药物或linker,payload经验更佳。有抗体开发、抗体工程、双抗经验的更佳。 3. Familiar with in vivo and in vitro efficacy and safety evaluation of ADC or other antibody related drugs, such as cellular based cytotoxicity assays, PMBC activity assays, CDX/PDX models, DMPK, NHP toxicology. 熟悉ADC或抗体药的各种体外体内药效与安全性评估,例如细胞毒性、PBMC活性、CDX/PDX模型、药动药代分析、猴毒理分析等等。 4. Have good English reading and writing skills, familiar with the search of various literature. 具有良好的英文读写能力,熟悉各类文献的检索。 5. Preferably with CMC or IND experience. 有CMC与临床申报经验更佳 6. Good communication skills and execution skills. 具有良好的沟通能力和执行能力。 7. Have good pressure resistance and strong sense of responsibility. 具有良好的抗压能力,责任心强。 8. Have a good sense of teamwork and full of cooperation spirit. 具有良好的团队意识,富有合作精神。