Keeping microbes alive,
from discovery to shelf.

Fifteen years taking live microbial products from strain discovery through GMP manufacturing — across therapeutics, food, and agriculture. Now advising the companies doing the same.

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About
Kevin Roelofs

Kevin Roelofs, Ph.D.

Founder, Greenbeard Consulting  ·  Co-founder & CSO, Ample Agriculture

I build live microbial products — and the teams and processes that get them made. Over fifteen years I've set scientific strategy, stood up R&D and CMC organizations, and carried non-model microbiology from bench to shelf-stable drug product: strict anaerobes, fastidious gut organisms, engineered strains, the ones that don't cooperate.

Greenbeard is how I do that work for other companies. Clients usually arrive with a hard problem rather than a general question — a strain that won't survive lyophilization, a process that won't transfer cleanly to a CDMO, a CMC package that has to hold up in front of a regulator. I've been on the inside of each of those, at companies that shipped.

I work across therapeutics, food, supplements, cosmetics, and agriculture, and I'm as comfortable writing the regulatory section as running the experiment.

Scientific strategy Live biotherapeutics Strain & process development Lyophilization & formulation Fermentation scale-up CDMO management cGMP manufacturing Regulatory CMC (IND/CTA)

Where the experience comes from

Fifteen years inside companies that had to make this work — an early-stage startup I co-founded, a clinical-stage engineered-strain company, and a microbiome therapeutics company I joined as its eighth employee.

Ample Agriculture
Co-founder & Chief Science Officer
2023 — present

I set and own the scientific strategy for a first-in-class feed additive that reduces enteric methane from cattle and other ruminants — helping farmers feed more people at lower economic and environmental costs through a novel mechanism.

Raised over $0.5M in pre-seed capital and non-dilutive grants (Agriculture Canada, USDA), established the company's foundational intellectual property, and recruited the academic and contract collaborators who ran the in vitro and in vivo campaigns — delivering a definitive evaluation of the lead product for roughly $200K.

Novome Biotechnologies
Director / Associate Director, Strain Process Development
2021 — 2023

Owned the path from clinical strain to GMP drug product for genetically engineered live biotherapeutics, internally and across CDMOs. Managed cGMP manufacturing and authored the CMC regulatory filings in the US and Canada that enabled patient dosing in Phase 1 and Phase 2a trials.

Improved lyophilization survival by more than 6 logs CFU/g by using molecular genomics to find and repair mutations in the clinical strain genome, and invented a directed-evolution approach that improved survival for every strain tested. Demonstrated engraftment in mouse and non-human-primate models, enabling the move from frozen liquid to shelf-stable oral solid dosage forms.

Finch Therapeutics
Associate Director, Bioprocess Development → Senior Scientist & CMC Project Manager → Research Scientist & Microbiology Team Lead
2016 — 2021

Joined as the eighth employee and stayed through the company's growth into a public company. Hired and led the Microbiology team that isolated and characterized more than 10,000 gut and environmental strains, building the high-throughput culture, isolation, and genomic pipelines behind the discovery engine.

Later led a four-person process development team and a development and manufacturing budget over $3M across multiple CDMOs — advancing 50+ anaerobic and fastidious strains through CMC screening and 10+ through GMP master cell banking and 200L drug-substance development. Drafted the R&D and CMC strategy for the multi-strain consortium behind the Takeda IBD partnership, and tech-transferred anaerobic cell banking, fermentation, drying, formulation, and analytics to international CDMOs.

Training
Ph.D. and postdoctoral research
2008 — 2016

Postdoctoral fellow at Brigham and Women's Hospital and Harvard Medical School with Dr. Laurie Comstock, working on the molecular mechanisms of interbacterial antagonism that govern strain-level composition of the human gut.

Ph.D. in Cell Biology & Molecular Genetics from the University of Maryland with Dr. Vincent Lee, where I invented a high-throughput protein–ligand binding assay and mapped second-messenger signaling networks in human pathogens. B.S. in Molecular Biology, College of William & Mary.

How I can help

Engagements run from a focused technical review to standing in as your interim scientific lead. Most start with the part of the program that's stuck.

Discovery & Strain Selection

Select the right genes, microbes, and communities for your lead candidates. From screening strategies to hit identification and characterization.

Preservation & Freeze Drying

Formulation and lyophilization expertise to deliver shelf-stable live microbial products. Optimizing viability from lab scale through commercial production.

CDMO & cGMP Manufacturing

End-to-end CDMO selection and management for cGMP-compliant production across cosmetics, food, dietary supplements, and therapeutic products.

Regulatory & CMC

CMC strategy and filings for live biotherapeutics, dietary supplements, cosmetics, and food — including the IND and CTA sections I've written and defended before.

Get in touch

Let's connect

Working on something in this space — a program, a problem, or an idea worth pressure-testing? Send a note. It comes straight to me.