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Expert, Science & Technology (Analytical Process Development)

Technology

Development Manager

No

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 Expert, Science & Technology (Analytical Process Development), is responsible for developing and optimizing phase-appropriate analytical assays used for testing and characterization of drug substance/drug product as well as in-process pool product quality attribute and concentration testing.<br><br>Your responsibilities will include, but are not limited to:<br><br>• Provides analytical testing support across the entire process (e.g. upstream, downstream, drug product) in support of exploratory studies targeted at developing, demonstrating and characterizing new technology platforms and innovative upgrades for existing platforms. <br>• Perform analytical method development, transfer and testing support in the TR&D laboratory<br>• Work with QC and/or Analytical Sciences group to transfer analytical methods into TR&D lab<br>• Perform in-process and drug substance/drug product assays.<br>• Design, perform, and guide lab experiments in support of AAV process development and process characterization studies using some of the following techniques: ddPCR, qPCR, ELISA, analytical ultracentrifugation, spectrophotometry, particle analysis, HPLC, CE, SDS-PAGE, and Western blot.<br>• Author experimental protocols/reports and related to analytical methods<br>• Participate in assay troubleshooting and method performance improvement projects<br>• Represent TR&D laboratory in cross-functional teams (QC, Analytical Sciences, Technical Development, Manufacturing Sciences and Technology, etc.)<br>• Collaborate with contract testing labs to ensure successful completion of testing projects<br>• Manage the use and maintenance of scientific equipment and instrumentation, computer systems<br>• Support test sample forecasting, submission, progress tracking, and results reporting<br>• Participate in exploratory assay development efforts to bring new technologies or assays to the Analytical Development department.<br>• Other related job duties as assigned.<br><br>[#video#https://www.youtube.com/watch?v=Mo1vwtVPVA0{#400,300#}#/video#]