John Casper

Background

About John Casper

Dynamic, analytical thinker with excellent problem-solving skills with more than 20 years of high-profile biotechnology experience. Strong project management skills enhanced with a multi-disciplinary technical background. Matrixed team leadership experience (up to 8 direct reports) including government contracts and oversight of CxO’s. Experienced in authoring health authority filings and method validation documents. Subject matter expertise in immunoassay, flow cytometry, potency assay, stability and PCR techniques. Biomarker and analytical method development with strong molecular genetics and gene therapy/virology background. Skilled at transferring research knowledge into validated marketed products. Solid people management skills, driving development teams to complete projects and achieve goals. Experienced in the biopharmaceutical regulated development and QC release of phase appropriate analytical methods for viral vectors, pluripotent stem cells, allogenic and CAR-T immunotherapies and companion diagnostics. Specialties: CTL and CDMO oversight and supervision • Method Validation and Transfer • Next Gen Sequencing (NGS) Antibody Development and Characterization, PCR/nucleic acid based analytical methods • Cell-based potency assays Analytical Method Development • Cross-functional Team Leadership • MSD ECL immunoassay CAR-T • AAV Technical Writing / SOPs • GMP Manufacturing • siRNA Multi-disciplinary SME • EP-25A • Biomarker Development CofA review and release • Phase appropriate specifications •Reference Standard Traceability Cross-Functional Teaming • Regulatory filings• AKTA FPLC • Companion Diagnostics • Lyophilization QC Release of Allogeneic autologous and Pluripotent Stem Cells for Clinical Trials Regulatory Submissions • R&D • Bioanalytical Methods • Gene and Cell Therapy • ISO 13485 Risk Mitigation