Job Title:
Director of R&D
Lead the end-to-end process development lifecycle for biosynthetic, medical device products from concept through scale-up and commercial manufacturing transfer. This role requires a strong background in process development with experience in leading cross-functional teams to design, develop, and implement robust processes that meet quality, regulatory, and cost objectives.
Key Responsibilities:
* Develop process development strategies and roadmaps to ensure on-time, on-budget delivery with robust process performance.
* Design, run, and analyze design of experiments (DOE) and other statistical methodologies to understand critical process parameters and their impact on quality and yield.
* Collaborate with technical operations, manufacturing, and quality teams to select equipment, automation, and process technologies; evaluate capital project needs and contribute to budget planning.