Diverse experience with cell therapy regulatory writing, process development strategy, planning, and execution
CMC
Regulatory
Business Analytics
Wendy joined DHC in 2021 with a background in process/platform design and optimization of T-cell therapies for phase I and pivotal phase manufacturing.
In her support of Dark Horse clients, Wendy has been particularly focused on regulatory writing support, technical gap analyses, CDMO selection, and technology transfers. When supporting regulatory writing needs from clients, Wendy excels at quickly coming up to speed on clients’ processes, identifying gaps in documentation, and working with the client to generate polished, concise, and accurate content to support their communications with regulatory bodies.
Before DHC, Wendy’s immunology career started at the Louis Picker Lab, located in the Vaccine and Gene Therapy Institute at the Oregon Health & Science University. She developed her passion for immunology while supporting the Picker Lab’s HIV vaccine research and their flow cytometry core.
Wendy joined Juno Therapeutics (now Bristol Myers Squibb) in 2016. She spent her time there focusing on process development of CAR-T and TCR-based cell therapies. In her most recent role, Wendy led process development for a TCR-based cell therapy at BMS. She was responsible for delivering a novel and robust platform process that incorporated new technologies, reagents, and process targets through the design and execution of statistically-powered multi-donor studies. Wendy also has extensive experience authoring process development plans, batch records, and reports in support of process transfer to cGMP manufacturing.
In addition to traditional process development work, Wendy enjoys analytical development projects. She has experience developing bioassays for raw materials testing as well as analysis and execution of flow cytometry experiments for product characterization.
Juno Therapeutics/BMS
Associate Scientist, Process Development
Vaccine and Gene Therapy Institute at OHSU
Research Assistant, Picker Lab
University of California, Berkeley
B.A. Integrative Biology
