职位描述
主要职责1、负责为IND 授权或临床研究阶段的项目开发生物大分子活性测定方法，并完成方法验证和转移；2、负责为生物制品工艺开发、生产提供高质量的生物活性方法检测支持，确保方法和操作符合相关指导原则/法规、公司标准操作规程和安全法规；3、负责起草、审核生物活性测定方法开发报告、方法确认、转移和验证方案及报告，操作规程等；4、负责起草并审核 IND 和 BLA 备案相关文件；5、协助质量控制团队和其他相关部门沟通合作，以支持项目推进；6、参与相关实验仪器的维护和培训，完成上级领导交办的其它工作。任职资格1、学历及专业要求：博士具备0-2年或硕士具备3-5年在免疫学、分析化学、生物化学、细胞生物学、分子生物学或其他相关领域经验；2、工作技能：具备生物制品相关的生物活性测定方法开发、验证、转移和检测方法故障排除方面的专业技术知识，包括基于细胞的生物测定法、ELISA方法等，以支持完成按USP、EP和 ChP 相关法规要求进行的批放行和稳定性检测，及支持产品的特性鉴定等；熟悉 FDA/EMA/CDE的监管要求以及适用于生物制剂、药品的 ICH 和 GMP 指导原则；3、软性素质：具备良好的沟通协调能力，能够批判性思考，具有良好的自驱力，工作认真注重细节，能适应快节奏的工作环境，并能够根据不断变化的优先级迅速调整工作4、语言技能：英文口语流利者优先；5、其他：具备监管核查相关经验更佳。Main ResponsibilitiesDevelop, validate and transfer bioassays for IND enabling or clinical stage projectsProvide the high-quality bioassay support for biologics production process development, manufacturing, while ensuring compliance with relevant guidelines/regulations, company SOPs, and safety regulations.Communicate, collaborate, and cooperate with QC functional teams and other departments to support routine project managementPrepare, review technical documents including bioassay development reports, method protocols, qualification, transfer and validation protocols and reports, etc.Draft and review IND and BLA filing documentsQualificationsPh.D. with 0-2 years of experience, or Masters with 3-5 years of experience in Immunology, Analytical Chemistry, Biochemistry, Cell Biology, Molecular Biology, or other related fields.Technical expertise in bioassay method development and transfer, validation, and troubleshooting Biologics product-testing methods, including cell-based bioassay, ELISA to support product characterization, lot release and stability testing according to USP, EP, and ChP requirements.Previous experience with regulatory inspections is a plusKnowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticalsExcellent interpersonal, verbal, and written communication skillsAble to think critically and demonstrate troubleshooting and problem-solving skillsSelf-starter and self-motivated; organized with good attention to detailComfortable working in a fast-paced environment and able to adjust workloads based on changing priorities
