Job title: Director of Process Development
Location: Limerick, 30-40% in first year
Benefits: Top salary, bonus, pension, healthcare and car allowance


Overview:
As a Process Development Director you will lead the design, optimization, and scale-up of manufacturing processes for biosynthetic, medical device products. This R&D role partners closely with Technical Operations, Supply Chain and Quality to ensure robust, scalable, and compliant processes from early development through to commercial production



Role:

• Lead the end-to-end process development lifecycle for biosynthetic, medical device products, from concept through scale-up and commercial manufacturing transfer
• Define and execute the process development strategy, roadmaps, and risk management plans 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
• Develop scalable, robust manufacturing processes that meet quality, regulatory, and cost objectives; drive design for manufacturability and design-to-cost initiatives
• Plan and manage technology transfer activities from development to production lines, including support in process validation (IQ/OQ/PQ), commissioning, and start-up support
• Partner with Formulation, Technical Operations, Manufacturing, and Quality teams to select equipment, automation, and process technologies; evaluate capital project needs and contribute to / manage budget planning

• Bachelor’s degree in Chemical Engineering or a closely related field with an advanced degree (MS/PhD) preferred
• 10+ years of experience in process development, process scale-up, and manufacturing transfer in medical devices or similarly regulated industries (e.g., pharma, biotech) with hands-on leadership responsibilities
• Deep knowledge of GMP/ISO 13485 quality systems, CAPA, change control, document control, and regulatory expectations for medical devices
• Proven expertise in process characterization, design of experiments (DOE), statistical analysis, and robust process validation (IQ/OQ/PQ)
• Strong background in one or more of the following process areas common to medical devices: polymer processing, lyophilization, polymer milling, coloration, and sterilization, with a bias toward reliable, scalable polymer manufacture
• Demonstrated success in technology transfer from development to manufacturing to meet commercial demand
• Excellent project management, planning, and budget management skills; ability to manage multiple programs concurrently
• Travel: occasional travel to sites, vendors, and customers as needed (typical expectation: light to moderate travel). Role is EU based, with a possible need to relocate to the manufacturing location with <1yr of hire
• Collaborative mindset with the ability to build strong partnerships across R&D, Technical Operations, Quality, Regulatory, and Supply Chain