Matt brings over 25 years of industry experience, specializing in CMC analytical strategy and implementation for cell and gene therapies. He has overseen stability programs, analytical method validation, QC preparedness, and regulatory submissions from early-stage development through BLA approval. Additionally, he has more than 15 years of expertise in developing and validating PK and ADA assays in GxP-compliant settings, as well as in designing assays to evaluate vaccine responses.
Skills include:
· Deep expertise in CMC analytical strategy, including method validation, stability programs, specification setting, and reference standard lifecycle management.
· Regulatory CMC authoring and leadership, with successful contributions to IND, IMPD, BLA submissions, agency responses, and the accelerated approval of TECELRA® in 2024.
· Proven ability to lead analytical method lifecycle activities, including tech transfer to GMP QC labs.
· Extensive experience in managing global CTO partnerships and acting as SME on analytical validation
· Strong foundation in PK and ADA assay development, validation, and regulatory support across clinical development stages.
· Skilled in building and directing cross-functional teams, aligning stakeholders across development, QC, and regulatory functions.
