12,000. The number of associates worldwide working together to reimagine medicine!
The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.
**Shift Position: Sunday - Wednesday | 8am - 6pm
The Associate Expert, Science & Technology will perform bioanalytical testing and other activities in functions supporting the Bioanalytics department related to development/clinical operations at our Cell and Gene Therapy GMP facility.
Your responsibilities will include, but are not limited to:
* Perform bioanalytical testing in support of clinical release strategies and activities compliantly following appropriate SOPs and procedures. * Document results within electronic and paper based systems accordingly. * Peer review and archive analytical data in lab documentation systems. Support monthly review of laboratory logbooks and monthly laboratory cleaning. * Handle reagent and equipment inventory for assigned areas of responsibilities. * Perform daily equipment startup and shutdown; ensures cleanliness of laboratory working areas * Participate in deviation investigation/CAPA implementation in a timely manner and support OOS/OOE/OOT and deviation investigations. * Follows GxP quality policies and procedures. * Ensures all assigned training is completed within required period and draft presentations as the need arises. * Identify process improvements to support 5S and Lean projects. * Interface with regulatory agencies during audits. * Knowledge of LabWare LIMS, QC data systems and other GMP/GLP quality systems (eSOPs, TEDI, etc). * Work on shifts covering daytime/evening and one or both weekend days. Ability to work different shift, weekends and overtime will be required. Your shift will be fixed according to business need. * Performs other job duties as assigned.