上海招聘

Shanghai ChemPartner, Co. Ltd, a leading CRO based in Shanghai, China, provides Chemistry, Biology, Pharmacology, DMPK/Toxicology and CMC services to over 400 global pharmaceutical and biotech companies.
In order to expand our Toxicology capabilities, we are current looking for a Study Director-Mammalian Toxicology who will be responsible for conductance and execution of preclinical safety studies in non-rodent and rodent species; GLP compliance experience with large molecule and non-human primate will be plus.

Responsibilities:
1. Develop study proposal and protocols in response to client’s request and ensures that the protocol, including any changes is in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines
2. Overall supervision of the staff assigned to studies, scheduling and coordinating initiation and conduct of studies as per the protocol.
3. Review, analyze and interpret study related data for accuracy and compliance and prepare final report for submission to the client
4. Maintain close and effective communication with clients, and report study progress in a timely manner
5. Trouble-shoot and provide ongoing guidance to team members as needed
6. Participate in and may host client visits
7. Work closely with QA to ensure the study conduct is in compliance to GLP requirement, including personnel training, SOP drafting, other documentation, archiving, etc

Requirements:
1. PhD with >2 years or MS with >4 years of relevant industrial experience, preferably in GLP setting
2. Hands-on and supervisory experience on pre-clinical safety studies in animals
3. Previous experience with preclinical studies in non-human primate and biologics assays will be a significant plus
4. Knowledge and experience in regulatory guidelines such as FDA, OECD, SFA will be a significant plus
5. Must be able to work in a dynamic working environment and be multi-tasking.
6. Good communication skill and report writing skills are must.

上海睿智化学研究有限公司成立于2002年，是一家世界领先的科研外包服务机构(CRO)，秉承着创新驱动、客户至上的服务理念，致力于为全球制药公司和生物技术公司提供全面且高品质的新药研发服务。
公司业务涵盖了抗体早期研发、小分子早期研发、药理药效、药代药动及早期毒理、生物药CMC、化药CMC、临床样品生产等新药研发各环节，为客户提供整合一体化的新药研发外包服务，已经服务过的国内外制药企业和生物医药技术公司1000余家，其中包括全球排名前20位的医药和生物技术企业。

公司在全球设立了6个办事处，专职研发人员2000人，海归科学家150人，拥有大规模最先进的科研、办公设施、实验动物设施、cGMP级别的公斤级实验室以及医药中间体生产设施。公司通过坐落于张江、奉贤、启东、成都和南旧金山五个重要研发基地持续不断为来自全球范围内客户长期提供优质的服务。