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Senior Scientist, Analytical Development - Bioassay (344117BR)

Business Development

Strategic Planning



San Diego, California, United States

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 organizational title for this role will be Senior Expert, Science & Technology. He/she/they will initiate, direct and execute 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#{#400,300#}#/video#]<br><br>Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to