Who we are

A unique team of consultants offering authentic expertise and unparalleled global reach.

Dr Mike Ironside, PhD

Mike gained his PhD in Organic Chemistry from the University of Dundee and then undertook a postdoctoral fellowship with Dr Richard Haynes at the University of Sydney.

After returning to the UK, Mike worked for GSK in the process development department, mainly involved in tech transfer of developmental APIs from lab/pilot scale into Glaxo’s global manufacturing network.

He then moved to Portugal to manage Hovione’s pilot plant in Lisbon, handling a range of projects from scale up of R&D chemistry right through to small scale validation campaigns.

Mike moved to the US in 1998 to join AMRI as head of small scale GMP manufacturing and subsequently held positions of increasing seniority within the organization.   As Global Director of Project Management, Mike was responsible for AMRI’s entire portfolio of clinical development projects across its global network. In his role as Vice President of Chemical Development, Mike oversaw growth of the group from a single site with 30 scientists to a global network of numerous sites in USA, UK and India and over 500 staff.

Mike has also experienced the unique challenges of working in a small biotech company, serving as Vice President CMC at both Anacor Pharmaceuticals and Biosignal, where he managed the internal teams involved in progressing clinical assets. .

In 2012, Mike was appointed GM of Hovione’s TTC in NJ, a site which had underperformed since its inception in 2007. During his tenure over the next three years financial and operational performance improved markedly to become the top performing site within Hovione.

Most recently Mike has served as CSO at New Zealand Pharmaceuticals, with responsibility for advancing their portfolio of novel bile acid compounds.

In 2019, Mike started Strathmore Pharma Consulting Associates to provide CMC, regulatory, quality systems and project management consulting services to the pharmaceutical and biotech industries.

During his career, Mike is proud to have contributed to the development of more than a dozen approved drugs including Alosetron, Viracept, Vyvanse, Tavaborole and Zejula.

 

Areas of Expertise

  • Global Scientific Leadership – R&D, CMC Project Management and cGMP Manufacturing Operations
  • P&L Management and Budget Planning
  • Talent Recruitment, Coaching and Development
  • Knowledge of Regulatory and Compliance issues as related to the development of pharmaceuticals
  • CMC activities related to IND, NDA and ANDA regulatory filings
  • Authored CMC sections for regulatory filings (US, EU)
  • ICH guidelines germane to DS manufacture
  • DoE/CPP evaluations in support of QbD Filing
  • Process Registration/Validation/Commercialization
  • DS RSM Strategies
  • Outsourcing and Technology Transfer across a global manufacturing network
  • Phase appropriate analytical and process development activities
  • Supply chain development and launch prep
  • cGMP DS/DPI Manufacturing
  • Controlled Substances
  • Handling of highly potent/cytotoxic compounds
  • Spray Drying/HME/Enabling Formulation Development