Job Description
工作地点：连云港
岗位职责：
1.负责分析方法的开发和验证，包含但不限于原料药、中间体、起始物料及制剂等中的杂质分析方法的开发及验证，并进行研究方案和报告的撰写；
2.负责各项目研究过程中，遇到的疑难分析问题的解决，比如结构类似物分析方法开发，大极性化合物分析方法开发，复杂基质前处理方法开发等等；
3.负责其他分析相关攻坚问题的解决；
4.能熟练掌握不同类型分析仪器原理、操作，运用多种联用技术解决分析问题；
5.负责仪器的日常维护与保养。
任职要求：
1.博士及以上药学、分析化学、物理化学等相关专业；
2.独立开发过多个体系的色谱方法，包括小分子化药和多肽类，有有机化学和药物降解化学研究基础者优先，有手性异构体分析分离经验或多肽消旋肽研究经验者优先，有丰富的样品前处理和制备样品后处理经验者优先；
3.具有合规合作意识，具备良好的沟通能力，能吃苦耐劳，工作积极主动。
Job Responsibilities:
1.Lead the development and validation of analytical methods, including (but not limited to) impurity profiling methods for APIs, intermediates, starting materials, and drug products; author related study protocols and reports.
2.Resolve complex analytical challenges during project execution, e.g.:Method development for structural analogs、Analysis of highly polar compounds、Sample preparation in complex matrices
3.Address critical analytical issues requiring advanced technical expertise.
4.Demonstrate mastery of analytical instrumentation principles, operations, and hyphenated techniques (e.g., LC-MS, GC-MS) to solve analytical problems.
5.Perform routine instrument maintenance and calibration.
Qualifications:
1.Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Physical Chemistry, or related disciplines.
2.Proven experience in developing chromatographic methods for diverse systems (small molecules/peptides). Preferred candidates will have:Background in organic chemistry/drug degradation chemistry、Experience with chiral isomer separation or peptide racemization studies、Expertise in complex sample preparation/post-treatment
3.Strong GMP compliance mindset, excellent communication skills, resilience to demanding workloads, and proactive problem-solving attitude.