- Responsible for the lifecycle of regulated and clinical samples of biotherapeutics in various matrices to be tested in ligand binding assays on various instrument platforms.
- Responsible for the routine and non-routine maintenance of lab equipment (e.g. plate washers, plate readers) used in support of regulated and clinical studies.
- Assist with quality control of operational procedures and software applications in accordance with departmental SOPs and bioanalytical methods.
- Sample lifecycle management and lab equipment maintenance to be governed per departmental SOP. Attention to detail to ensure accurate execution and documentation of these processes in a regulatory compliant manner.
- Knowledge of GLP/GCP and working in a regulated environment is highly desirable.
- Implement various processes needed to manage a sample’s lifecycle which includes accession, check-in and disposal within a laboratory management system (LIMS). Become proficient in LIMS to conduct these activities in a dynamic environment. Collaborate with external groups to resolve sample discrepancies. Assist in the transmission and formatting of clinical files for the importation/exportation of clinical data from LIMS.
- Execute routine maintenance of lab instrumentation as required per departmental SOPs.
Regards,
Anuj Mehta
732-947-3452