CMC Analytical Strategy & Bioanalysis Consultant
Matt is a seasoned analytical development expert with over 25 years of experience in both biotech and global CDMO environments working across early-phase development through to BLA. He has led CMC strategy initiatives across diverse modalities, including cell and gene therapies, monoclonal antibodies, and recombinant proteins. He has extensive expertise in bioanalytical methods, QC readiness, regulatory filings, and worldwide laboratory coordination. This expertise allows him to progress complex biopharma programs through clinical development.
Skills include:
- Analytical strategy & CMC planning: Led method validation programs, stability studies, and regulatory submissions tailored for advanced therapies
- Bioanalytical assay development: Designed and implemented PK/ADA assays using ELISA, SPR, qPCR, and flow cytometry in clinical and GMP settings
- Global lab oversight: Managed bioanalysis activities across multiple continental labs and CDMOs, ensuring harmonisation and regulatory compliance
- Clinical & QC readiness: Supported assay transfer, GMP integration and sample management for Phase I–III clinical trials and release testing
- Regulatory submissions: Has authored CMC modules, responded to agency queries and supported client interactions with FDA, EMA & MHRA
Matt has a hands‑on approach and excels at transitioning analytical methods from early research environments into regulated environments allowing delivery of robust methods that meet both scientific and commercial milestones.
