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.
COO & MANAGING PARTNER

~20 years of C&GT operations experience, combining strategic vision and cross-functional technical leadership in the field.

CFO

20+ years of experience supporting public and private businesses using his financial, legal, and business background.

MASTER PRACTICE EXPERT, REGULATORY

CMC subject matter expert with over 25-years of US FDA-regulatory review experience that encompasses the life-cycle of regenerative medicine advanced therapy (RMAT) product development from pre-submission interaction with FDA through filing of market authorization applications. 

GENERAL MANAGER, DHC Europe Ltd. SENIOR PRINCIPAL

Cross-functional project leader in biopharmaceutical management of international clinical development, regulatory submissions, and development strategy.

PRINCIPAL

Twenty years of experience in CMC for C&GT, including viral vectors, plasmids, and cell therapies.

PRINCIPAL

Cell and gene therapy expert with over 15 years of experience in stem cell-based platforms. Leads cross functional teams towards successful preclinical development programs.

PRINCIPAL

Cell and gene therapy scientist with 15 years of experience leading research, preclinical, and process optimization for preclinical and clinical stage development programs in industry and academia.

PRINCIPAL

Over 25 years of experience in the development and commercialization of advanced therapeutics in multiple geographies, with particular focus on characterization, analytical development/validation, and quality control.

PRINCIPAL

EU Qualified Person and Practice Expert with 15 years of experience of IMP and commercial manufacture, quality, validation, clinical trials, regulatory submissions, and remediation activities.

PRINCIPAL

An established leader in the development and manufacturing of cell-based therapeutics with a strong technical/scientific background in stem cell biology and cell therapy CMC development and manufacturing.

PRACTICE EXPERT, INTELLECTUAL PROPERTY and VICE PRESIDENT, LEGAL AFFAIRS

Intellectual property (IP) expert and registered patent attorney with over 10 years of combined experience in biologics and cell therapy patent prosecution and IP strategy at various stages of product development and commercialization.

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.
SENIOR CONSULTANT

10+ years working in academic, biotech and contract development and manufacturing organizations with a primary focus on manufacturing allogenic and autologous cell therapy products.

SENIOR CONSULTANT

Data-driven engineer and subject matter expert in cell cryopreservation, process optimization, scale-up, and technology transfer of cell therapies and clinical diagnostics.

SENIOR CONSULTANT

10 years of GMP Quality expertise supporting the manufacture, release and distribution of IMP, Drug Substance and Drug Product, with a focus on Quality System design and remediation.

SENIOR CONSULTANT

Ten+ years experience across academic and industry in translational medicine, GMP manufacturing for viral vectors and various cellular products, as well as regulatory filing for clinical and commercial stage C&GT products.

SENIOR CONSULTANT

Ten years of contract development and manufacturing organization (CDMO) experience, primarily focused on program & alliance management.

SENIOR CONSULTANT

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.

SENIOR CONSULTANT

Corporate strategy, finance, and commercial operations expert with more than seven years experience supporting and leading teams in the Cell and Gene Therapy space.

SENIOR CONSULTANT
Brings broad engineering expertise to help DHC clients tackle their device design, instrument development, and process engineering challenges throughout their products’ lifecycles.
SENIOR CONSULTANT

CMC project manager with 20 years of experience in the biopharmaceutical industry, from research & development to clinical phase and commercial manufacturing, including tech transfers of immunodiagnostic, personalized cancer immunotherapy, and C&GT products.

CONSULTANT

Bringing seven years of biotech experience focused on quality assurance, computer system validation, and clinical trial oversight.

CONSULTANT

Four+ years CDMO experience in gene therapy, focusing on analytical method development, tech transfer and validation.

CONSULTANT

Process engineer with 5 years of cell therapy experience including process, technology and device development, technology transfer and QA oversight of GMP manufacturing. Six Sigma Green Belt. 

CONSULTANT

Process engineer with experience in cell therapy process optimization and technology development and deployment. 

CONSULTANT

Brings cutting edge cell & gene therapy experience in both gene editing and stem cells.

CONSULTANT

Extensive and diverse experience with cellular therapy process development strategy, planning, and execution. 

CONSULTANT

Five years of experience across academia and industry, with expertise in immunobiology, clinical epidemiology and cell therapy process development and manufacturing.

CONSULTANT
12 years of experience in process development, GMP manufacturing and technology transfer of cell and virally-modified cell therapy products.
CONSULTANT

Bioengineer with 5+ years of experience focused on gene therapy viral vector process development as well as characterization and validation with an emphasis on AAV and lentiviral vectors.

ASSOCIATE CONSULTANT

Brings 10+ years of pluripotent stem cell biology know-how. Experience in tissue engineering, cell & gene therapies, tech transfer and validation.

SENIOR MANAGER, BUSINESS DEVELOPMENT

Business development professional and analyst focused on the advanced therapy space, with a background as a strategy consultant and as business development manager in a CDMO. 

SENIOR CONTROLLER

Financial leader with experience in financial and accounting operations: emphasis on growth, operational efficiencies, and building scalable processes.

SENIOR EXECUTIVE ASSISTANT

Responsible for scheduling meetings, travel, onboarding, conferences, and other events as well as providing C-suite support. 

ACCOUNTING MANAGER

10+ years of experience in accounting, financial reporting, audit, tax, operations, and operational accounting.

BUSINESS OPERATIONS SPECIALIST

Oversees internal operations and resource management, as well as supporting business development functions. 

CONTRACTS ADMINISTRATOR and LEGAL ASSISTANT

Responsible for preparing and maintaining contracts and providing general support to the VP Legal Affairs. Cecilia has over 10 years of experience as a legal assistant in the biotechnology field. 

ADMINISTRATIVE ASSISTANT

Responsible for providing administrative support across Dark Horse. Previous experience includes non-profit and arts administration as well as office management in Silicon Valley. 

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