Wantage, England, United Kingdom
Self-employed Bioanalytical Consultant Offering services to support regulatory compliant (GLP/GCP/GMP) analytical laboratories including: • Bioanalytical CRO selection, inspection and monitoring • Establishment/review of GxP laboratory quality systems • Process implementation, review and improvement for laboratory operations, sample logistics and data management • Assay design/development, trouble shooting and qualification/validation for large molecule PK/TK, immunogenicity (ADA screening, confirmatory, neutralising antibody activity, characterisation and vaccine efficacy) and biomarkers (protein and cellular) • SOP development and review • Bioanalytical study/phase plan and report writing and expert peer review