Operations Director, Chemistry in United Kingdom specialising in Extractables and Leachables
Michael manages Smithers' Extractables and Leachables (E&L) and Chemical Analysis consultancy team in the UK. He has been working with E&L for over 15 years both for Biopharmaceuticals and Pharmaceuticals, and joined Smithers in 2009.
Previously Michael worked in the validation department for one of the largest Single Use System suppliers and previous to that a petrochemical organisation.
Expertise: Extractables and leachables (E&L), chemical analysis, method validation and method development
Michael has used his expertise to solve the challenges of the assessment of E&Ls for Single Use System suppliers and users (bags, tubing, filters, connectors etc.) and Final Container Closure Systems (pMDIs, stoppers, vials, pre-filled syringes, cartridges etc.).
Michael’s team supports a diverse range of clients and industries require the support of analytical experts working within a cGMP and ISO17025:2017 environment.
Qualifications and professional accreditation
Michael has a BSc in Chemistry, and is a Member of the Royal society of Chemistry (MRSC).
- “Requirements of Pharmaceutical Packaging, Regulations and Developments in Pharmaceutical Packaging” – Les Journées Packaging 2010, Tunis, Tunisia, December 2010
- “How a CRO can Help and Deliver a Successful New Polymeric Medical Device to Market” – HuLST, Cologne, Germany, February 2011
- “The Parallels and Differences Between Food, Medical and Pharmaceutical Regulations” – Smithers E&L Conference, Rome, Italy, 2012
- “General Extractables and Leachables Points to Consider for Pre-Filled Syringes” – Visiongain- 5th pre-filled syringes –London 2012
- “E&Ls from COC Materials – the Supply Chain Perspective” – Smithers E&L Conference, London, UK December 2013
- Pharmaceutical Manufacturing and Packing Sourcer, Winter 2012 – “The Extractable Question”.
Call: +44 (0)1939 252 427
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