Production Project Manager
- My work focuses on the translation of two novel medical implants (intended for rotator cuff repair) from an academic research setting to the clinic.
- The implants, (BioPatch and BioYarn) are permanent implantable devices, manufactured from biodegradable polymers. Both devices show enhanced cellular infiltration upon implantation. These products hold the potential for improved patient outcomes, by providing biophysical cues to the endogenous cell population.
- Roles involve cleanroom manufacture of product to GMP standards, establishing QMS procedures for the products and navigating the relevant regulatory pathways to effectively evidence the pre-clinical safety and performance of the devices.
- I have previous experience in industry working with silk protein biomaterials and an educational background in tissue engineering and regenerative medicine.