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Expert - Preclinical Manufacturing - Drug Supply (347346BR)

Manufacturing and Production

Manufacturing Engineer



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 Associate Expert, Preclinical MFG (US/DS) Drug Supply, reports to the Sr/Manager of Pre-Clinical Manufacturing and is responsible for execution of pre-clinical manufacturing operations and processes at the Technical Research and Development site. <br><br>Note: This job description is relevant to positions in either the Upstream or Downstream Preclinical teams as specified in the job posting.<br><br>What you'll be doing:<br><br>• Produce high-quality pre-clinical material at a production/pilot scale in an early research and development setting, in support of the company’s pipeline and strategic objectives. <br>• Safely and compliantly execute daily lab operations for large scale processes in Upstream or Downstream, depending job specific assignment. <br>• Conduct experiments supporting large scale development and implementation of a closed system, scale-up, recovery, and purification processes for gene therapy.<br>• Support tech transfer of new products, technologies, and processes to ensure smooth transition from process development into GMP manufacturing.<br>• Author work procedures for new equipment as it is onboarded. <br>• Revise or review equipment procedures, development batch records, protocols and/or sample plans to ensure accurate content and useability.<br>• Work cross-functionally to obtain feedback and alignment regarding projects and potential modifications to current processes.<br>• Capable of evaluating and summarizing data using analytical methodologies, interpreting results, drawing conclusions and recommending options for future experiments to achieve project goals.<br>• Adhere to Novartis Development Quality requirements, including good documentation practices (ALCOA+). Appropriately document experimental procedures and results according to established guidelines, ensure training is current, and all Quality requirements are being followed.<br>Support site tours or information requests for internal and external audits of manufacturing facilities/processes and support responses to any observations received per procedure. <br>Responsible for maintaining quality standards to meet Novartis Quality requirements related to the pre-clinical manufacturing process. <br>Support small scale lab experiments, as needed.<br>Look for opportunities to implement operational excellence and continuous improvement. <br>Support lab equipment upkeep in collaboration with the site Engineering team.<br>Partner with Development Quality to ensure a quality and compliant manufacturing environment. <br>Support the leadership team to meet information requirements as needed for quality, compliance, and management reporting. <br>Don lab gowning as required.<br>Adhere to all EH&S policies, procedures and guidelines.<br>Other related job duties as assigned.[#video#{#400,300#}#/video#]