- 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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