With over 20 years of experience gained from working in the Biotech and Contract Research Organisation sectors, I bring a wealth of experience in analytical CMC across multiple modalities.

In addition to building and leading successful internal analytical teams, I have experience in developing phase appropriate analytical strategies, selection and management of CDMO's/CTLs, stability study set-up and management, gap analysis, specifications and writing and reviewing regulatory documents, analytical development, qualification and validation reports.

I have a pragmatic approach to analytical that also strives to give you the best guidance aligned with ICH, USP, EP and other regulatory guidances.