Description
The Advanced Research Projects Agency for Health (ARPA-H) is seeking independent validation and verification (IV&V) services for its Resilient Extended Automatic Cell Therapies (REACT) program. The REACT program is developing wireless implantable medical devices for the surveillance and treatment of chronic diseases. The IV&V services will include characterizing production of unmodified pancreatic cells, validating performance characteristics of performer cells, and preparing technical reports. The contractor will be required to provide qualified personnel, material, equipment, and facilities to perform the work.
* Key aspects of the job include:
* Characterizing production of unmodified pancreatic cells
* Validating performance characteristics of performer cells
* Preparing technical reports
* Providing recommendations aligned with FDA requirements
* Experience with Good Manufacturing Practices (GMP) for cell-based product biomanufacturing
* Experience with regulatory processes for bio-hybrid devices