scientist岗位职责

职责描述：
Job Description
We are seeking an experienced highly motivated SeniBioanalytical Scientist to join our team. The ideal candidate will possess extensive experience in LC-MS based bioanalysis, particularly in support of IND-enabling clinical studies, demonstrate strong project management, regulatory knowledge, leadership capabilities.
Key Responsibilities
• Lead execute LC–MS/MS–based bioanalytical studies supporting IND other regulatory submissions, ensuring high-quality data generation timely project delivery.
• Prepare, review, approve bioanalytical study reports in compliance with GLP requirements.
• Ensure all work complies with relevant regulatory guidance, including ICH, FDA, NMPA/CDE bioanalytical guidelines.
• Manage project timelines, coordinate resources across functional teams, ensure efficient project execution.
• Lead menta team of scientists, fostering collaboration, providing technical guidance, driving successful project completion.
• Identify resolve technical operational challenges in complex, multi-project environments.
• Maintain strict adherence to internal quality systems, SOPs, compliance requirements.
• Communicate effectively with internal stakeh
任职要求：
Qualifications
• Master’s PhD degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, a related field.
• Master’s degree candidates should have ＞5 years of relevant industry experience.
• Extensive experience in LC–MS/MS-based bioanalysis supporting IND-enabling clinical studies.
• Strong understanding of GLP principles regulatory compliance requirements.
• Familiarity with ICH, FDA, NMPA/CDE bioanalytical guidance.
• Proven project management experience, including resource coordination timeline management.
• Strong problem-solving abilities the capacity to work effectively in fast-paced, multi-project environments.
• Excellent written verbal communication skills in both English Chinese.
Preferred Qualifications
• Experience supporting both preclinical clinical bioanalytical studies.
• Experience in targeted proteomics fabsolute protein quantification.
• Extensive experience in large molecule bioanalysis, including monoclonal antibodies antibody–drug conjugates (ADCs).
• Experience in high-throughput bioanalysis method development.
• Priexperience in a large CRO environment is a plus.

职责描述：
1. 负责小分子生物分析技术的研究、开发和在临床实验中的应用。
2. 运用专业知识在临床试验中解决复杂的小分子生物分析技术问题。
3. 与团队协作，开发和优化小分子生物分析方法和流程。
4. 执行临床实验操作，进行数据分析和结果解读。
5. 负责撰写和修改关于临床实验的操作指南及相关文档。
任职要求：
1. 生物化学、分析化学、药学或相关领域的博士学位。
2. 对小分子生物分析技术有深入理解，包括但不限于HPLC、LC-MS、GC-MS等，并了解其在临床试验中的应用。
3. 具备扎实的实验操作技能和数据分析能力，能够在临床环境中进行高精度的实验操作。
4. 对临床试验流程和规范有深入理解，具备临床试验设计和执行经验。
5. 良好的团队协作能力和沟通技巧，能在压力下工作并满足项目要求。
6. 良好的英语读写能力，能阅读和撰写英文科技文献。

职责描述：
Key accountabilities:
1. Provide solutions fchallenging bioanalytical studies.
2. Responsible fbioanalytical new capability exploration.
3. Evaluate new assay, instrument, platform, especially those fnew modality drugs.
4. Lead project fbioanalytical studies, ensure timely delivery of analytical result.
5. As an upper manager in bioanalytical chemistry, in support of pharmacokinetics other studies.
6. Distribute studies, track studies resolve problem during method development sample analysis.
7. Comply with all internal external regulations, ensure proper record maintenance.
8. Present posters giveal presentations in conferences.
9. Write scientific publications (journal articles, patents, etc.).
10. Cross-department collaboration in support of integrated service.
11. Responsible fpeople quality improvement, provide lab lecture training to team members.
12. Responsible fcommunicating with the clients in telephone conference face-to-face interactions.
任职要求：
Requirements:
1. Ph.D. in a related science discipline, working experience training in analytical chemistry, equivalent experience.
2. Strong hands-on experience with liquid chromatography-mass spectrometry and/ligbinding assay based analytical platforms fsmall molecules and/large molecules.
3. Strong communication skills, both written verbal, outstanding interpersonal skills.
4. Must be able to openly share information work in a team-oriented manner inder to accomplish performance objectives.
5. General bioanalytical knowledge.
6. Skillful at reading, understanding, writing,al communication in both English Chinese.