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Expert - Preclinical Manufacturing - Drug Supply (347346BR)
Job Description 12,000. The number of associates worldwide working together to reimagine medicine!
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 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.
Note: This job description is relevant to positions in either the Upstream or Downstream Preclinical teams as specified in the job posting.
What you'll be doing:
• 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.
• Safely and compliantly execute daily lab operations for large scale processes in Upstream or Downstream, depending job specific assignment.
• Conduct experiments supporting large scale development and implementation of a closed system, scale-up, recovery, and purification processes for gene therapy.
• Support tech transfer of new products, technologies, and processes to ensure smooth transition from process development into GMP manufacturing.
• Author work procedures for new equipment as it is onboarded.
• Revise or review equipment procedures, development batch records, protocols and/or sample plans to ensure accurate content and useability.
• Work cross-functionally to obtain feedback and alignment regarding projects and potential modifications to current processes.
• Capable of evaluating and summarizing data using analytical methodologies, interpreting results, drawing conclusions and recommending options for future experiments to achieve project goals.
• 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.
Support site tours or information requests for internal and external audits of manufacturing facilities/processes and support responses to any observations received per procedure.
Responsible for maintaining quality standards to meet Novartis Quality requirements related to the pre-clinical manufacturing process.
Support small scale lab experiments, as needed.
Look for opportunities to implement operational excellence and continuous improvement.
Support lab equipment upkeep in collaboration with the site Engineering team.
Partner with Development Quality to ensure a quality and compliant manufacturing environment.
Support the leadership team to meet information requirements as needed for quality, compliance, and management reporting.
Don lab gowning as required.
Adhere to all EH&S policies, procedures and guidelines.
Other related job duties as assigned.