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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Director of Process Development


Reference:TG- Director Location: Limerick
Limerick City
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Account Director, Chemist, Country Manager, Director of Clinical Research, Engineering Manager, Manufacturing and Technology Manager, Manufacturing Executive, QA Director

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


Experience required:
  • 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


Does this sound like your next career move for 2026? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR [email protected]