Our team of Cell and Gene Therapy professionals bring deep technical expertise to help you tackle the unique challenges of our exciting young field.
FOUNDER & CEO
Founded Dark Horse Consulting in 2014. Over 20 years of experience in CMC leadership of cell and gene therapy companies.
Nineteen years of experience in CMC for cell and gene therapies, including technology transfer, process development, quality by design, manufacturing, regulatory and facility design.
Bioengineer with expertise in cell therapy, gene therapy, and combination products. Lean Six Sigma Black Belt.
PRACTICE EXPERT, QUALITY
Quality and regulatory scientist with 25+ years of experience providing guidance for successful FDA submissions, technology transfers and validation associated with human cellular and tissue based products, biologics, and medical devices.
Data-driven engineer and subject matter expert in cell cryopreservation, process optimization, scale-up, and technology transfer of cell therapies and clinical diagnostics.
Over eight years of experience in process development, cGMP manufacture, technical writing and project management for leading cell and gene therapy companies and academic labs.
Brings broad engineering expertise to help DHC clients tackle their device design, instrument development, and process engineering challenges throughout their products’ lifecycles.
VICE PRESIDENT OF FINANCE & CUSTOMER RELATIONS
Responsible for all Finance functions, contract negotiations, and customer relationship management. Prior to DHC, she spent 14 years in Finance and Business Management functions at Fortune 500 companies.
Responsible for a broad range of administrative tasks, including calendar management, travel bookings and expense reporting. Prior to Dark Horse, held Executive Assistant roles at a range of companies in the software, retail, and health services industries.