职责描述：

1. 负责小分子药物生物分析研究工作开展，包括生物样本LC-MS/MS方法开发、样品预处理及样品的定量分析；

2. 负责实验数据的收集整理分析，原始记录的书写、整理工作，撰写实验报告，并对研究结果进行解释；

3. 应用Winnonlin软件计算药代动力学参数。

4. 撰写、维护及升级SOP，严格按照SOP开展生物分析检测工作。

5. 负责仪器的维护，特别是LC-MS/MS的日常维护和故障诊断。

任职要求：

1. 分析化学和药学等相关专业，硕士学历，本科学历加2年以上生物分析的相关工作经验；

2. 熟练操作LC-MS/MS，熟悉仪器原理及维护，了解质谱分析原理；

3. 具有团队精神，工作认真负责，态度积极，善于沟通，有较强的学习和解决问题的能力

岗位职责：

1. 主要负责小分子化合物的纯度检测、纯化分离工作，协助解决分析分离时遇到的问题；

2. 熟练掌握药物分析基本原理，可操作质谱导向高压液相制备、中高压液相制备等分离仪器完成样品的纯化工作，并完成相应的分析检测及后处理;

3. 动手能力强，可进行相关分析仪器的维护维修工作，并通过定期保养、预防性维护等方法对分析仪器进行管理;

4. 所指派的分析、纯化工作，分析数据维护、整理及报告书写；

5. 协助完善SOP等规范化文件；

6. 协助分析分离仪器规范化管理，确保分析分离工作顺利进行。

任职要求：

1. 本科及以上学历，五年以上相关工作经验。

2. 热爱分析分离及药物研究工作，熟悉HPLC、LCMS、NMR等分析仪器的维护操作及排障维修，有岛津、安捷伦LCMS使用经验者优先；

3. 熟悉多种样品前处理方法，能解决多组分分离方面问题，有分析方法开发经验，具有独立开发检测方法的能力；

4. 责任心强，富有团队协作精神；

良好的沟通能力和问题分析解决能力。

岗位职责:

1. 精通各类有机合成反应，可参与小分子药物研发项目的工作，包括药物先导化合物和候选化合物的设计、合成和纯化。

2. 能够熟练进行各种文献的查阅和图谱解析，包括一维和二维核磁谱图解析。

3. 能够熟练地完成多种化学反应，独立设计和进行多步有机合成合成反应。

4. 熟悉合成化学实验室常见仪器设备的原理和使用 （LCMS， HPLC, MPLC, NMR etc.）。

5. 全面了解化学实验安全操作规范，能够预见可能发生的安全隐患；在实验室的安全和运行方面能够承担一定的责任。

6. 参与维护实验室安全及日常运行。

任职要求:

1. 有机化学或药物化学相关专业，博士学历，或硕士毕业5年及以上相关行业工作经验，有公开发表的的文章或专利；

2. 精通各类有机合成反应；

3. 诚实、正直，责任心强，具团队合作精神，对安排的工作具有较强的执行能力；

4. 具有熟练的英语阅读和书写能力。

Responsibilities：

1. Drive small molecule medicinal chemistry program on:

Molecular design and SAR evaluation Implementation of organic syntheses and problem solving

Directing a team of internal and external (CRO) chemists to execute chemistry plan Preparation of experimental for report and patent filing

Interacting cross-functionally to collect vital data Presenting resulting and data in program meeting and to review committee

2. Serve as chemistry leader on:

Participating on cross-functional project teams to evaluate, prioritize and set strategy to positively influence project direction and timelines

Build strong working relationship with internal and external colleagues and organizations Training, building and growing the chemistry team, and ensuring maximal productivity

3. Acting as a resource and mentor to team members

Managing external (CRO) FTE Sourcing of reagent and its procurement cost effectively

Drive quality and speed to meet departmental and company goals

Grow to become an influential drug hunter and scientist

Qualifications：

1. PhD in Organic or Medicinal Chemistry

2. At least 3 years industry experience in small molecule medicinal chemistry

3. Excellent communication skill

4. Sufficient language proficiency to present in English

Responsibilities:

1. Ensure that the Quality Management System (QMS) is effectively implemented and complies with all applicable domestic and international laws, regulations and standards

2. Contribute to managing and improving QMS

3. Support QMS-related actions including but not limited to

 Preparing, reviewing and implementing quality assurance policies and procedures

 Assisting in vendor quality management including planning/performing routine inspections and audits

 Conducting Incident Investigation, Root Cause Analysis, and Impact assessment

 Documenting quality assurance activities and creating/approving audit reports

 Providing/Coordinating specific quality trainings to relevant employees

Qualification requirements:

1. Minimum 3 years of experience in QC and QA activities in the pharmaceutical, biochemical, or food industry

2. Bachelor degree or higher in science related field with laboratory experiences

3. The capacity for new experiences and challenges

4. Willingness to take increasing responsibilities while learning at the job

The ability to commit to the team's mission over individual interests

Primary Responsibilities:

• Provide preclinical safety expertise and strategy for pre-clinical and clinical development programs from pre-clinical drug candidate selection to IND enabling and clinical trials

• Apply a broad understanding of toxicology, pharmacology, DMPK and regulatory sciences to design all types of toxicology studies required to support drug development of biopharmaceuticals

• Ensure that the preclinical safety plan is aligned with the clinical development plan and regulatory guidelines (ICH, FDA, GLP, etc.)

• Serve as Preclinical Safety team leader for multiple programs and contribute to the program’s goals and deliverables

• Identify and manage contract research laboratories (CRO) for preclinical safety studies; review reports; ensure they are using systems and processes in compliance with all relevant regulatory standards

• Write and review documents for INDs / regulatory section submissions; represent the company as the pre-clinical toxicology expert before regulatory authorities

• Serve as a subject matter expert to provide input for due diligence of potential external partnership programs

Qualifications:

• 10+ years of combined toxicology, drug development and regulatory experience in a biotech, biopharmaceutical or CRO setting

• Extensive knowledge and expertise with in vitro and in vivo toxicology study conduct and reporting

• Familiar with applicable regulatory guidelines; prior experience with regulatory agency interactions is preferred

• Proven leadership and management skills, including the ability to interact effectively with CRO personnel and internal/external experts for the conduct of toxicology studies

• Good communication and technical writing skills in English. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts

Education:

• Ph.D. or equivalent in Toxicology or closely related field

• Toxicology board certification is a plus