Job Title: Process Development Leader About the Role This is a unique opportunity to lead the process development lifecycle for biosynthetic and medical device products from concept through scale-up and commercial manufacturing transfer. The successful candidate will be responsible for defining and executing the process development strategy, roadmaps, and risk management plans to ensure on-time, on-budget delivery with robust process performance. 1. The ideal candidate will have extensive knowledge of GMP/ISO 13485 quality systems, CAPA, change control, document control, and regulatory expectations for medical devices. 2. A strong background in one or more of the following process areas common to medical devices: polymer processing, lyophilization, polymer milling, coloration,