Senior Expert, Science & Technology (Analytical Development Bioassay)
Location: San Diego, California
Internal Number: 344117BR
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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.
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.
* Plan and execute experiments that contribute to bioassay development, optimization, qualification/validation of bioassays suitable for drug product stability studies and lot disposition. * 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. * 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. * Assist in authoring of technical reports and SOPs. * Work with junior research associate on experimental design, troubleshooting, assay optimization and data interpretation as needed. * Interpret and present data at group and department meetings. * Collaborate within Bioassay group and provide support to collaborating functional groups as needed * Monitors and evaluates completion of tasks and projects. * Participate in exploratory assay development efforts to bring new technologies or assays to Analytical development * Conducts work in compliance with cGMP, GDP, safety and regulatory requirements. * Thoroughly analyzing data and ensuring the data quality. Provides analysis and evaluation of material and products at all stages of development process. * Maintains broad knowledge of state-of-the-art principles and theories in Bioassay * Makes major contributions to scientific literature and conferences. * Serves as in-house and outside consultant. * Interfaces with various departments. * Other related job duties as assigned.