Daniel Martin
Biopharmaceutical CMC leader enabling end-to-end development to commercialization.
- Role
- Associate Director, Program Design at FUJIFILM Biotechnologies
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Daniel Martin
I am a biopharmaceutical leader with over a decade of end-to-end CMC experience, currently operating with portfolio responsibility for late-stage biologics programs. I guide development from early phase through process validation and commercial readiness, owning global drug substance and drug product strategy, tech transfers, and external manufacturing oversight at leading CDMOs.My work has contributed to accelerated regulatory pathways, including FDA Breakthrough Therapy, EMA PRIME, Operation Warp Speed, and orphan drug programs—often in fast-moving environments that demand cross-functional coordination across Quality, MSAT, Regulatory, and Supply Chain.I excel at building strong partnerships with internal teams and external manufacturing organizations to deliver on complex program goals. My approach combines technical expertise with clear governance, financial acumen, and the ability to influence stakeholders at all levels, from cross-functional teams to C-suite executives.
Experience
Associate Director, Program Design
Dec 2025 — Present
Education
Northeastern University
Master of Science - MS, Regulatory Affairs
North Carolina State University
Bachelor of Science (BS), Chemical Engineering concentrating in Biomanufacturing
2011 — 2015
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