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Senior Principle Investigator/Principle Investigator

Responsibilities:

1. Conduct method development and validation for multiple client projects both domestic and international

2. Support preclinical toxicokinetic studies under GLP regulations (FDA, OECD, sFDA) and ensure compliance with policies, procedures and regulations

3. Prepare validation protocols and study reports for assigned studies in both English and Chinese

4. Be the point of contact for client interaction for multiple clients to ensure effective project support and negotiate timeline as needed

5. Direct and mentor bioanalysts under supervision to ensure efficient and effective support for assigned projects

6. Provide expertise and advice in various aspects of method development for junior staff

7. Involve in process optimization and strive for quality, efficiency and continuous improvement via scientific development and employment of new technology

8. Assist department manager to supervise the operation of the department, including hiring and training scientific staffs, revising SOP or drafting SOPs

9. Administrative or managerial responsibility as needed and qualified

Qualifications:

1. BS, MS, or PhD degree in analytical chemistry, chemistry, related biomedical discipline that enable the individual to perform the work function effectively; equivalent experience also satisfy the requirement

2. Experience and skills in analytical techniques such as HPLC, LC-MS and sample extraction

3. Ability to effectively perform typical wet lab experiments and sample processing without supervision

4. Ability to follow protocols, SOPs and policies under GLP guideline

5. Have good understanding of GLP regulations and compliance

6. Must be customer and goal-oriented, quality conscious, observant in lab operations, and able to trouble-shoot common LC-MS assay issues

7. Working experience in regulated (GLP) LC-MS bioanalysis is desired and experience in Watson LIMS is a plus

8. Must be able to communicate with clients in both Chinese and English, orally and in writing

9. Must be able to work well with others to achieve business goals; possess good interpersonal skills to lead a group as needed