Brendan Walsh

Background

About Brendan Walsh

Extensive pharmaceutical R&D experience has taught me that great products require great science, great teams, and great systems. The challenge? These functions often struggle to understand each other.My experience has given me the ability to bridge Development Sciences, Business Strategy, Digital and Data, and Quality Compliance. Starting on the lab bench, I've built expertise across formulation science, process engineering, regulatory affairs, and enterprise digital transformation. I can explain drug product release profiles to your CFO in terms of market advantage and help your IT team understand why data structure drives innovation.CORE EXPERTISEDrug Product Development & CMC: Led formulation and process engineering across multiple dosage forms from development through regulatory submissions (IND/NDA) to commercial manufacturing. Presented QbD design spaces to FDA auditors during Pre-Approval Inspections, translating complex statistical models into regulatory narratives.Digital Transformation: Architected unified LIMS/ELN platforms serving 500+ scientists at Haleon, structured formulation data for automation and AI, driving cycle time reduction. Bridged scientific needs with IT capabilities, explaining business value to senior leaders.Quality Systems & Strategic Leadership: Quality System Lead for Product Development at Haleon, authored enterprise standards across global operations. Managed $15M+ platform portfolios and built communities of practice for scientists, retired 600+ legacy procedures while enabling business flexibility.RECENT WORKLed digital transformation and Quality System development at Haleon. Successfully navigated GSK/Pfizer merger and system integration, launched global quality standards, and built data architecture enabling both innovation and efficiency.CURRENT AVAILIBILITYPursuing senior leadership roles in product development, CMC, or R&D digital transformation. Best fit: growing biotech, specialty pharma, consumer healthcare, or life sciences technology firms needing someone who bridges Development Sciences, Business Strategy, Digital and Data, and Quality Compliance.Available for consulting engagements and expert consultations through professional networks including due diligence, technology assessment, and strategic advisory projects.EDUCATIONB.S. Chemistry, Fairleigh Dickinson University (Summa Cum Laude)| Adjunct Professor of Chemistry, Sussex County Community College, practicing what I preach about making complex concepts accessible.