Implement, perform and develop experimental methods and techniques based on company needs. Ensure the established methods/techniques meet the company scientific standards, and act as the primary subject matter expert in these techniques. Ensure the developed method are maintain to date by tracking advances in the field. Supervise/train staff in experimental techniques/technology systems related to the lab.
Plan and coordinate activities on clearly defined programs and track progress in relation to timelines/ timetable.Coordinate daily work planning within Cell Bioassays team and to organize the practical aspects of additional measurements in the study. Being point of contact for study-related matters, to coordinate and participate in several study-based activities within own team and participate in resource monitoring and scheduling.
Produce quality results within the required time frame, as well as analyze study related data/reports by applying scientific and technical principles and draw basic conclusions. To review routine data, monitor and escalate deviations. To lead in determining root cause of unusual findings, and provide CAPA (Corrective and Preventive Actions).
Support the in vivo department by performing clinical pathology analysis. It includes the testing of sample chemistry, hematological assessment, and various other assays.
Support to plan, develop and coordinate qualification/validation set-up of new assays and equipment. Able to configure complex systems. Manage/troubleshoot existing equipment and ensure adequate maintanence.
Perform general administrative work such as tracking the supply of daily consumables, perform risk assessment for new chemicals, and maintain and calibrate equipments. Coordinate with vendors/suppliers on procurement matters.
Prepare simple technical reports. Develop/maintain/update standard operating procedures (SOP) and work instructions (WKIs).
To take up additional specialist tasks in other areas and/or to perform cross functional activities.
The Talent
Diploma with more than 2 years experience (eg, experience with cell biology and molecular biology methods like flow cytometry, ELISA, PCR, and/or clinical chemistry and hematology analyses).
Good understanding on regulatory guidelines such as FDA, ICH, OECD GLP and TGs related to in vivo toxicology study.
Experiences in the area of bioassay development and validation will be advantageous.