A Scientific Leader with extensive experience of developing biopharmaceutical and gene therapy products, in the academic, public, and private sectors and through freelance consultancy.
Skills include:
• Biopharmaceutical and gene therapy development, viral vectors for gene transfer
• Analytical Sciences (QC, Biochemistry, Cell-based methods, Immunodiagnostics, Biomarkers, Bioanalysis, Characterisation, Nucleic Acid Technologies/analysis)
• Process and Product Control testing strategies
• Pre-clinical and clinical development
• Submission documentation and Regulatory Affairs (CTD modules 2, 3, 4)
• Scientific advice and discussion with competent authorities
• GMP, GLP, GCP, ICH, EMEA and FDA (CBER/CDRH) regulation
