We’re looking for a candidate to fill this position in an exciting company.
Plan and perform activities on clearly defined programs, and track progress in relation to timelines/ time table. Implement and develop experimental methods and techniques based on the upcoming needs of the studies. Formulate short & simple runs, and establish the methods/techniques to meet high scientific standards, and act as the primary subject matter expert in these techniques.
Plan and perform daily work within bioanalytics and organizational levels, to organize the practical aspects of additional measurements in the study. Be the main point-of-contact for in vivo studies.
Produce quality results within the required time frame, as well as analyze study related data & reports by applying scientific and technical principles to draw basic conclusions. Review routine data, monitor and escalate deviations. Identify and troubleshoot and resolve issues & gaps in processes to improve operational efficiency.
Participate in several study-based activities within own team, perform daily routine measurements and perform analyses for non-routine measurements on equipment / systems for all studies as needed and act as the Subject Matter Expert. Participate and contribute in risk assessments. Plan, develop and perform activity related to qualification & validation set-up of new analytical endpoints and equipment. Able to configure complex systems.
Maintain list of consumables required for the study and raise purchase requests in timely manner.
Perform calibration & preventive maintenance of laboratory instruments. Manage and troubleshoot existing equipment and ensure calibration & maintenance schedules are updated as per instrument SOP. Be the system/process owner.
Prepare technical method development reports.
Minimum Masters or PHD in biomedical sciences, chemistry biotechnology or any relevant field
Minimum 3 years’ of strong experience in the handling of chromatographic instruments such as LC-MSMS, HPLC and software like Analyst, Masslynx and Chromeleon
Familiar with ICH/USFDA guidelines, and have good knowledge of OECD GLP guidelines and AAALAC principles