プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Michael D.に依頼

United States

I help founders and investors turn early scientific ideas into manufacturable, fundable realities

プロフィール概要

I’m a Ph.D Molecular Virologist and CMC / Tech-Ops leader who thrives in the missing middle—that early stretch between discovery and execution, when there’s a great idea but no clear path to material, data, or value. My work is about building the foundation that turns early biology into something real, testable, and ultimately investable. Over the past 10+ years, I’ve helped advance viral vector and protein-based platforms from discovery through GMP and IND (including Module 3 authorship). I’ve built and led high-performing teams, delivered industry-leading AAV manufacturing processes, and co-authored patents on novel plasmid and process innovations. My background spans process development, AAV manufacturing, CDMO partnerships, and regulatory strategy—bridging R&D, CMC, Translational Sciences, and Clinical Ops to move innovation efficiently from concept to clinic. I’m drawn to early-stage, venture-backed environments where science meets execution. Whether consulting or in a full-time role, I focus on helping teams shape bioprocess strategy, reach proof-of-concept, and build the IND-enabling processes that bring new ideas to life. Strategic & Scientific Execution • Guiding platform design, process strategy, and R&D road-mapping to reach key inflection points. • Running Scientific Diligence Sprints—rapid literature, data, and IP reviews to support go/no-go and investment decisions. • Translating academic or seed-stage concepts into development plans, experimental designs, and partnership frameworks. Technical & Operational Expertise • Process & Analytical Design — building scalable expression, purification, and analytical frameworks that generate fit-for-purpose data. • Tech-Transfer & CDMO Management — driving GMP readiness through documentation, package authoring, and on-site oversight. • IND CMC Strategy & Authorship — connecting development data to clear, compliant regulatory narratives (Module 3). • AAV Process Development — end-to-end design, scale-up, and troubleshooting. • GMP Lot & Clinical Supply Readiness — batch record review, acceptance criteria, and clinical labeling/logistics. • Research & Operations Leadership — SOP and CRO oversight, experimental planning, and milestone-based execution. Fractional & Full-Time Roles Available for consulting or leadership engagements supporting platform build-outs, early CMC strategy, CDMO management, and IND enablement. I specialize in bringing order and momentum to the early stages of biotech growth.hy, IEX, TFF/UFDF). Expertise: Gene Therapy, Manufacturing, CMC-Regulatory, RNA and DNA virus (Adeno/AAV, AnelloVirus, Zika, West Nile, Dengue, Yellow Fever, HCV), Protein therapeutics

専門分野

• ★ Virology
• ★ Bioprocess Development
• ★ Gene Therapy
• ☆ Separation & Purification
• ☆ Molecular Virology
• ☆ Pharmaceutical Manufacturing

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing, General Proofreading & Editing

Research Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Operations Consulting, Scientific and Technical Consulting, Manufacturing Consulting

Product Development Formulation, Stability/Shelf Life Testing, Manufacturing, Quality Assurance & Control (QA/QC)

職務経験

AD Technical Operations and CMC

Affinia Therapeutics

8月 2023 - 現在

Freelance Consultant

Principal Consultant

1月 2019 - 現在

Head of Process Development and Manufacturing Innovations

Affinia Therapeutics

8月 2023 - 5月 2025

P.Sci: Head of New technologies and Innovation

Affinia Tx

11月 2020 - 8月 2023

Sr. Scientist Bioprocess: Cellular and Vector Engineering

Ring Therapeutics: Viral Vector Gene Therapy Company

6月 2019 - 11月 2020

Sr. Fellow: Bioprocess/Vector and protein engineering

AstraZeneca/Medimmune

6月 2018 - 6月 2019

Research Fellow: Structure and Molecular Virology

Purdue University

8月 2013 - 6月 2018

Postgraduate Fellow: Hepatitis C Virus

Yale University Medical School

6月 2012 - 6月 2013

学歴

Ph.D Structural and Molecular Virology

Purdue University

8月 2013 - 7月 2018

認定資格

• 認定資格の詳細は未入力です。