生物大分子活性分析高级科研员

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 Responsibilities
Develop, validate and transfer bioassays for IND enabling or clinical stage projects
Provide 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 management
Prepare, review technical documents including bioassay development reports, method protocols, qualification, transfer and validation protocols and reports, etc.
Draft and review IND and BLA filing documents
Qualifications
Ph.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 plus
Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals
Excellent interpersonal, verbal, and written communication skills
Able to think critically and demonstrate troubleshooting and problem-solving skills
Self-starter and self-motivated; organized with good attention to detail
Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities