Ten years supporting CMC activities in CG&T; including process development, technology transfer, risk assessment, regulatory strategy and filing authorship, along with Quality by Design based development and project management.
Sara has spent over nine years working with biotech companies and academic labs focusing on applications of human primary cell cultures and autologous and allogeneic cell therapy products for therapeutic applications. She joined Dark Horse Consulting in 2016, bringing her expertise in aseptic and cGMP manufacturing process development, risk analysis, CMC and regulatory filings, facility design and project management to advise growing cell and gene therapy companies.
Sara’s range also encompasses experience in managing cross-regional technology transfer, Design of Experiments, establishment of supply chain, and leading root cause analysis for gene therapies and autologous (CAR-T, immuno-derived and iPSC) and allogeneic cell therapies.
While at ViaCyte, Inc., Sara co-led the design and build-out of a ~700 ft. pilot plant and established documentation and operational functionality of the facility, which generated over 350 cryopreserved vials of ViaCyte’s cell product, PEC-01™ and facilitated the successful formal tech transfer of improved cell process to the GMP manufacturing team. She was also responsible for the process development of fill/finish processes and cGMP documentation development, along with co-authorship, design and execution of several IND-enabling verification studies.
Most recently, at Organovo, Sara was the lead subject matter expert and study director for ExVive™ Human Kidney Tissue, launched in September of 2016 and also established the first GLP compliant batch records and control at the company. She was responsible for supervising all timelines, supply requirements and upstream logistics to manufacture the first three commercial product builds for ExVive™ Human Kidney Tissue.
EXAMPLES OF RECENT WORK
- Directed international technology transfer of a cell therapy processes
- Provided hands-on support of key pre-clinical studies at a partnering CRO
- Prepared JMP statistical analysis and design of experiments for multiple clients in the U.S. and internationally
- Contributed regulatory and clinical process-related technical writing
Scientist, Process Development
Senior Associate, Technical Operations
Senior Associate, Process Development Engineering
Humboldt State University
B.S. Cellular Molecular Biology