Apply a strong understanding of GLP and bioanalytical guidelines when participating in the evaluation and selection of CROs for nonclinical and clinical assay validation and sample analysis; develop robust human bioanalytical assays for transfer to CROs and provide scientific oversight of method transfer, validation, sample analysis, troubleshooting, deviations, data quality, timelines, and final study reports. PhD in Biology, Pharmacology, Immunology, Biochemistry, or a related scientific discipline with 8-10 years of biotechnology, CRO or pharmaceutical industry experience following completion of the PhD; alternatively, MS/MSc with 12-15 years of relevant industry experience following graduate training.