Senior Expert, Science & Technology (Analytical Development Bioassay)

12,000. The number of associates worldwide working together to reimagine medicine! <br><br>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.<br><br>The Senior Expert, Science & Technology (BioAssay), initiates, directs and executes the Development and optimization of cell-based potency and other functional bioassays in a team environment of phase-appropriate bioassays that are used for drug substance and drug product stability and lot release testing as well as characterization studies.<br><br>• Plan and execute experiments that contribute to bioassay development, optimization, qualification/validation of bioassays suitable for drug product stability studies and lot disposition. <br>• Optimize and troubleshoot cell-based assays as well as other plate-based assays using variety of platforms including but not limited to ELISA, MSD, high-content imaging and luminescent/fluorescent plate reader in support of developing release and characterization assays for gene therapy products. <br>• Participate (or lead) method qualification/validation in a cGMP setting and may be involved in the method transfer to internal and/or external QC laboratories. Support tech transfer of methods to internal QC group and/or CROs.<br>• Assist in authoring of technical reports and SOPs. <br>• Work with junior research associate on experimental design, troubleshooting, assay optimization and data interpretation as needed. <br>• Interpret and present data at group and department meetings.<br>• Collaborate within Bioassay group and provide support to collaborating functional groups as needed<br>• Monitors and evaluates completion of tasks and projects.<br>• Participate in exploratory assay development efforts to bring new technologies or assays to Analytical development<br>• Conducts work in compliance with cGMP, GDP, safety and regulatory requirements.<br>• Thoroughly analyzing data and ensuring the data quality. Provides analysis and evaluation of material and products at all stages of development process. <br>• Maintains broad knowledge of state-of-the-art principles and theories in Bioassay <br>• Makes major contributions to scientific literature and conferences.<br>• Serves as in-house and outside consultant. <br>• Interfaces with various departments. <br>• Other related job duties as assigned.<br><br><br>[#video#https://www.youtube.com/watch?v=Mo1vwtVPVA0{#400,300#}#/video#]