Samantha is a Director and Principal consultant of GRA with experience spanning over 20 years’ working for Biopharmaceutical Companies including GlaxoSmithKline, Ipsen Biopharma, Lonza and Emergent Biosolutions. Sam 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 complex 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 technical project managements as well as outsource management of CMO selection through to implementation.
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