Paul Hurley

Senior Director | Process Product Development | People Leader | Pharmaceutical Lifecycle | CMC | Clinical Development and Supply | Commercialisation | Process Optimisation | Technical Transfer | Equipment and Facility

Loughrea, County Galway, Ireland

About

Strategic and results-driven Senior Director with over 20 years of technical and people leadership across global pharmaceutical development and commercialization. Proven success in both small biotech and large pharma environments, guiding cross-functional teams to deliver scientifically rigorous, patient-focused solutions. Known for cultivating deep scientific insight and translating it into robust, scalable processes that consistently yield high-quality products. Combining sharp analytical acumen with an authentic, inclusive leadership style, I inspire teams to perform at their best. I drive results by articulating a clear vision, fostering talent, and championing a culture of engagement and integrity — always prioritizing what’s right for the product and the patient. Key Skills: Research and Development (R&D) · Product Development · CMC · Drug Delivery · Complex Dosage Form · Bioavailability · Process Engineering · Cross-functional Team Leadership · Budgets · Resource Planning · Facility Planning · New Product Introduction · New Product Launch · Equipment and Facility design · Commissioning and Qualification · GLP · GMP · Safety · Compliance and Quality · Clinical Development · Clinical Supply · Packaging Selection · Stability · Scale-up · Process Validation · Technical Transfer · Regulatory Filing · Life Cycle Management · Process Trouble shooting · Business Strategy · Risk Based Approaches · QRM · DOE · Lean Development · Regulatory Oversight · Relationship Building · Contract Development and Manufacturing · CDMO oversight · Project Management · People Management · Team Development · Career Development · Coaching · Mentoring

Experience

  • Senior Director, R&D Organisation Lead at Novo Nordisk
    May 2024 - Present · 2 yrs 2 mos

    Guided the Athlone development team of up to 48 people (Formulation, Analytical, Process, Regulatory, Facility, Equipment) in planning, budgeting, and integrating into the Novo Nordisk ways of working and systems, reporting to the Corporate Vice President of Oral Product Development

  • Alkermes (On-site)
    • Senior Director, Process Development
      Jul 2022 - May 2024 · 1 yr 11 mos

      Directed the site Process Development team and supported the global Process Development team, including defining, driving and delivering on corporate strategy and inspiring and managing development teams to bring well understood products to market. Responsible for strategy, budgeting, resourcing and technical delivery from GLP tox supply to commercial launch and ongoing life cycle management and optimisation, reporting to Vice President, Head of Pharmaceutical Development

    • Director, Process Development
      Jan 2017 - Jun 2022 · 5 yrs 6 mos

      Provided functional leadership of the Athlone Process Development group (approx. 28 professionals), including product strategy, resource planning, capex and operational budget planning and management, facility management/ownership. Engaged strongly as people leader, owning responsibility for team culture and performance, training and career development. Linked delivery to strategy as member of Site Leadership team and global R&D senior management team, reporting to Senior Director, Product Development.

    • Associate Director, Process Development
      Feb 2012 - Dec 2016 · 4 yrs 11 mos

  • Manager, Product Development and Scale-up at Elan Pharmaceuticals
    Mar 2011 - Apr 2012 · 1 yr 2 mos

  • Senior Process Development Engineer - Process Improvement and Technology Transfer at Elan Pharmaceuticals
    Apr 2002 - Mar 2008 · 6 yrs

  • Senior Manufacturing and Maintenance Engineer at SIGMA WIRELESS COMMUNICATIONS LIMITED
    Jan 2001 - Jan 2002 · 1 yr 1 mo