An experienced consultant who delivers results by developing and implementing risk-based strategies to analytical testing to support fast and robust product launches

An expert in Inhalation Product Development and Analytical Technical Transfer, with proven leadership and risk management acumen.

Andy is a Senior Consultant with over 23 years of experience in the Pharmaceutical industry. With a proven track record in both big Pharma and CDMOs, Andy has extensive knowledge in product development for inhalation and semi solid topical products resulting in many successful product approvals and launches.

Andy studied chemistry at the University of Central Lancashire and scientific instrumentation at Manchester Metropolitan University before starting his career in the pharmaceutical industry in 1993. Starting his career in the UK at a CDMO, he gained experience in analytical testing of inhaled products, supporting product registrations. Andy then spent 6 years at Sanofi-Aventis, developing metered dose inhaler and dry powder inhaler products and leading the new product introduction initiative to stream line and develop a robust and secure process for introducing new products to the Homes Chapel manufacturing site in the UK. Andy moved to the US in 2002 to lead a team in the pulmonary and nasal department at Cardinal Health, further enhancing his inhaled product development expertize. Andy continued in the Inhaled field at GSK for a number of years, developing DPIs and MDIs. Andy joined the Stiefel business unit of GSK and was the Senior Director of R&D Operations and Analytical Sciences, leading a global team of 40 scientists developing OTC and cosmetic topical products.

Most recently, Andy was Vice President of R&D at Recipharm in RTP, a CDMO offering a wide range of product development services.

Andy lives in Cary NC USA.

Examples of projects completed:

  • Implemented automation for complex analytical testing for inhalation products and successfully led tech transfer of these platforms to manufacturing sites
  • Developed and executed strategy to perform all stability testing at stability hub in India, successfully launching over 100 products with data generated on over 200 separate stability studies, realizing a cost saving of over $10 million.
  • Developed a robust risk based approach to qualify and release test over 90 new raw materials for semi solid topical products over an 18 month period.
  • Executed multiple development programs of dry powder inhaler (DPI), metered dose inhaler (MDI) and nebulizer products, from early phase development to marketing application.
  • Proven track record in delivering the analytical aspects of CMC submissions resulting in many product approvals.
  • Proven track record of managing director level leaders and high performing scientists.
  • Established risk management processes at a CDMO to enhance delivery and performance, along with internal auditing and business continuity planning procedures.
  • Experienced at managing internal and external projects and leading multidisciplinary teams.
  • Experience in Quality by Design (QbD) as applies to analytical methodology