Arnaud is a life science professional with more than 15 years of experience in biotech and academia, with a passion for cell and gene therapy. He developed an expertise in clinical phase research and technical operations, along with program management and operational excellence.

As a therapeutic developer and a service provider, he gained deep knowledge and experience in cell therapy product and process development, as well as a detailed expertise in GMP manufacturing of early- and late-stage clinical cell therapy products. He is proficient working and collaborating with any department, from Tech Ops to R&D to Clinical. 

Over the years, he built a solid knowledge of pre-IND, Phase I & Phase II studies, clinical trial design, FDA/Health Canada regulations including the submission of INDs and CTAs, Good Manufacturing Practices (GMP) and Tech Transfer, Good Laboratory Practices (GLP) as well as Translational Research and Clinical Biomarker / Product Characterization.

Inspired by accelerating scientific innovation to real-world clinical applications, Traci has overseen the implementation of operations in early-stage programs from pre-clinical development through Phase II clinical trials. She is a quality driven professional with two decades of experience in the Biotech and Cell Therapy industry leading Quality Systems, GMP operations, and Process Development teams.

Having experience overseeing in-house manufacturing operations and working on both the sponsor and service provider sides of contract manufacturing, she has a unique perspective on GMP implementation strategies. She employs analysis of Critical Process Parameters and Risk-Mitigating Strategies to lead Continual Process Improvement while maintaining operational excellence 

Traci has been directly responsible for building a Quality System foundation to support a Phase II clinical program, contributions to CMC and leading quality oversight of multiple IND submissions (FDA/Health Canada), training programs, and qualification of analytical methods.