Bioprocess Engineering & CMC Consulting
Direct technical support across facility design, equipment selection, vendor management, project management, tech transfer, validation, and CDMO oversight — from IND to commercial.
mRNA · LNP · Recombinant · Viral · Inactivated · Conjugates
DS & DP · IND → BLA · Tech Transfer · GMP · CDMO Oversight
Design of GMP manufacturing facilities, layouts, and equipment selection for DS and DP.
Management and oversight of GMP facility construction projects from design to commissioning.
End-to-end transfer execution, from project initiation to PPQ and closure.
End-to-end project management for GMP manufacturing projects, from scope definition to on-site execution and closure.
Evaluation, onboarding, and technical oversight of CDMO partners.
CMC and operational support to deliver clinical and commercial supply.
Equipment qualification from DQ through PQ and process performance execution to support manufacturing readiness.
Design and execution of cleaning validation programs in compliance with GMP requirements.
Validation of computerized systems in GMP environments, ensuring compliance with data integrity requirements.
Preparation for regulatory inspections and GMP compliance.
CMC documentation for regulatory submissions.
Technical training in bioprocess engineering, GMP, and validation.
Deep hands-on experience across the major vaccine and biologic platforms — from upstream process development through commercial manufacturing.
Anyone who has worked on a project between Japan and a global partner knows how difficult the coordination can be. That is exactly where I come in.
Based in Tokyo with fluent Japanese, VaxEng provides direct, in-country support for foreign companies operating in Japan and Japanese companies working with international partners.
Full technical engagement in Japanese, from facility floors to regulatory meetings.
日本のバイオ医薬品産業をグローバルにつなぐ
GMP facility build experience in Japan. Vendor and supplier audits conducted on behalf of foreign companies — in Japanese, on-site, with full technical accountability.
Identification and evaluation of Japanese CDMOs for foreign companies entering the market. Conversely, support for Japanese companies selecting and managing CDMOs outside Japan.
End-to-end tech transfer management in Japan — inbound and outbound. Project management support for manufacturing and CMC programs involving Japanese sites.
Technical interpretation during GMP inspections (PMDA, FDA, EMA). Business development support for companies seeking partnerships or market entry in Japan.
A platform and book series built to make bioprocess engineering and CMC easier to understand, for engineers, scientists, and anyone working in vaccine and biologic manufacturing.
Visit Resource HubBiopharmaceutical Engineer
CMC & Biopharmaceutical Manufacturing Consultant
Business Development · Author
Tokyo, Japan
日本語能力試験1級(N1) · JLPT N1
I am Head of Business Development at ARCALIS Inc., a Japanese CDMO specializing in mRNA vaccines and therapeutics. I grew up in Lyon, France, one of the world's historical centers for vaccine manufacturing, and have been working in vaccine manufacturing and technology transfer for over a decade.
I have worked on more than 15 vaccine programs across France, South Korea, Japan, India, Brazil, Argentina, and Mexico. My experience covers six vaccine technologies: attenuated, inactivated, subunit, recombinant protein, conjugated, and mRNA. I contributed to the delivery of two approved COVID-19 vaccines, one protein-based and one mRNA.
I led the construction of ARCALIS's drug substance manufacturing facility in Japan and managed the technology transfer of a self-amplifying mRNA vaccine from the United States to Japan. Before ARCALIS, I worked at Sanofi Pasteur in the Global Engineering department, managing drug substance manufacturing projects in South America and Asia.
I am fluent in Japanese and have been based in Tokyo for several years. I work comfortably across cultures and am equally at ease on a production floor, in a regulatory meeting, or in a business development context.
I am also the founder of Biomanufacturing Made Simple, a platform where I share knowledge on vaccine manufacturing, and the author of two books on the subject.