Hands-on expert in development, validation, and troubleshooting of biochemical and molecular biology assays for enzyme and nucleic acid identity, potency, and purity. Knowledgeable in theoretical and practical matters of protein purification. Graduate and post-doctoral background in molecular and cell biological research.Experienced and effective leader and manager; skilled at communicating with customers and colleagues. 13+ years industry experience implementing continuous improvement to further cGMP compliance of processes and documentation. Practiced at interpreting FDA and ICH guidances for practical application.Broadly experienced as technical writer of SOPs, assay validation, product stability and comparability protocols and reports, responses to client requests for proposal, peer-reviewed journal articles, grant applications, product user protocols, and marketing literature.