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Head of Process Engineering
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- We are seeking a Head of Process Engineering to join the Manufacturing, Science and Technology (MSAT) team and support ongoing process development, manufacturing of GMP grade material for company's Phase 1 and 2 clinical trials, technical transfer from preclinical to clinical Phase 2, IND authoring and agency interaction activities.
- The candidate will work with Chief Technology Officer to lead authoring the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met.
- The candidate must have a proven track record in supporting the development, scale-up, registration and manufacture of cell therapy processes.
- Collaboratively work across the broader CMC, regulatory and quality departments to deliver desired outcomes (including
- Stay up to date on relevant regulatory requirements and guidelines related to biologics process development and manufacture
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