Samantha’s experience spans over 10 years’ working in Analytical Development for Biopharmaceutical Companies including GlaxoSmithKline, Ipsen Biopharma, Lonza and Emergent Biosolutions. Sam is an established consultant who specialises in all aspects of Method Development and Validation, developing strategies, as well as advising or directly managing assay development and validation programmes for complex biological vaccines, therapeutics and biosimilars. In addition to this, Sam can provide is able to design and manage product stability studies and shelf life determinations. Sam has contributed to a number of CMC sections in regulatory agency submissions & scientific advice packs for biopharmaceutical products in Europe, USA and China.
Specific areas of expertise include assay qualification, development, validation and transfer (inter-laboratory and site) with a focus on the use of statistics to facilitate Quality by Design approaches and general CMC project outsource management from CMO selection through to implementation.
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