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Process Scientist/Process Engineer, Manufacturing Sciences MSAT

Status: Archived
CompanyArcturus Therapeutics
LocationSan Diego, CA
Expiration2024-02-03
How to Apply

https://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=13467e50-14e0-4ae3-b7af-fa2196c7c382&ccId=273966895617_8123&jobId=453368&lang=en_US&source=EN

  • Ensuring successful implementation of a desired mRNA Drug Product therapy for clinical and commercial cGMP manufacturing by supporting the Tech Transfer, Process Validation, and GMP Manufacturing phase
  • Perform various scale-up and technology transfer project tasks/activities such as evaluating process scale and manufacturability, evaluating facility fit and equipment capability, and determining manufacturing process control strategy
  • Lead stage-appropriate technology transfer teams and associated projects in support of New Product Introduction, Process Performance Qualification (commercialization), and Product Lifecycle Management
  • Providing technical leadership and subject matter expertise relating to buffer formulation, sterile filtration, TFF, and Fill/Finish/Lyophilization/Packaging to provide floor support, leading investigations, change control, process optimization, technical troubleshooting, and manufacturing process changes
  • Contribute to process FMEA, gap assessments, and creations of control strategy documents
  • Authors and reviews documents including batch records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports
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