Small Molecular Bioanalysis Director
- Responsible for small molecule bioanalysis in support of pre-clinical studies. Communicate with clients, evaluate business opportunities and participate discussions with clients on LC/MS/MS based small molecule bioanalysis strategy including method development, transfer, validation and sample analysis.
- Lead the method development and validation of LC/MS/MS assays used for TK, late stage DMPK (large animals PK/PD) and biomarker studies. Ensure scientific integrity and GLP compliance.
- Work/colleborate with Toxicology and DMPK services to deliver bioanalytical data to support tox and DMPK studies timely
- Manage the operation of small molecule laboratory and staffs
- Plan and provide immunology related training to staff as required
- Accountable for all business and operational aspects pertaining to pre-clinical small molecule bioanalysis for DMPK/Tox studies. Actively participle client visits, teleconferences to discuss client projects. Prepare proposals on bioanalysis method development, transfer, validation or sample analysis.
- Serve as the technical expert in small molecule bioanalysis to establish LC/MS/MS based assays to ensure method transfer and new method development for supported projects
- As laboratory director, ensure that (1) basic operation tasks are clearly defined, （2）staff assignment are appropriate for their level and capability, (3) assignments are completed within the timelines, (4) study personnel understand clearly their responsibilities and acknowledge relevant standard operating procedures (5) contingency plan is in place for unforeseen events that affects timeline and deliverables and the impact of any deviations from the study protocol and/or standard operating procedures on the quality and integrity of the study is assessed and recorded, and take appropriate corrective action if necessary, (6) Communicate effectively with the QA unit and address study related findings during the conduct of the study
- Communicate effectively with other departments/function areas. Set priority for the lab and allocate appropriate human resources/work schedule to ensure timely delivery.
- Plan and provide regular trainings to staff to ensure adequate training is provided to staff to execute the required work assignments.
- PhD degree or equivalent in chemistry fields with 8 years of work experience in GLP LC/MS/MS area, or equivalent trainings/experience acquired through work in the fields
- Hands-on experience in designing/conducting/monitoring small molecule bioanalysis studies (GLP and non-GLP)
- Expertise in LC/MS/MS techniques including knowledge of various MS and LC platforms especially ABSciex MS, Shimazu and Waters HPLC/UPLC)
- Experience in managing GLP laboratory and studies.
- Staff management experience of small molecule bioanalysis (GLP) functions
- Fluent oral and written English skills. Oversea education and working experience highly preferred.
Any applications,pls contact:Cui_yining @wuxiapptec.com;firstname.lastname@example.org