Biotech Operations & Systems
Practical operating systems for growing biotech companies.
When science outpaces operations, BiOS makes the cross-functional gaps visible — and turns them into a clear Now / Next / Later plan.
Process scale-up → material demand → supplier exposure → release specs → inventory → scheduling. BiOS connects the chain so leadership can decide.
The pattern
Technical capability can outrun operational maturity.
Emerging biotechs often discover the hard constraints late — not inside one function, but between them. Materials, quality, facilities, data, and ownership collide when scale-up gets real. BiOS is built for that moment: systems thinking that produces decision-useful priorities, not a generic maturity checklist.
v0.1 offer
Operational Scale-Up Assessment
A fixed-fee engagement for emerging biotech and life-science teams moving toward scale-up, manufacturing, or more mature operations.
Current → future operations map
How process, equipment, materials, quality, data, and people must evolve together.
Cross-functional gaps & risks
The consequential interface failures — not an exhaustive audit of every SOP.
Now / Next / Later roadmap
Sequenced actions with dependencies, so leadership knows what to decide this quarter.
How it works
Clear scope. Concrete deliverables.
Short discovery
Clarify stage, constraints, and the operational transition you’re navigating.
Systems review
Map interfaces across process, materials, equipment/facilities, quality, data, and ownership.
Decision package
Receive a bounded assessment with prioritized risks, dependencies, and a sequenced roadmap.
Not included by default: exhaustive SOP review, detailed engineering design, validation packages, or full implementation projects.
Founder
Lee Stevens
Chemical engineer with ~15 years across consulting and biotech operations — spanning process/MSAT, manufacturing, materials and supply chain, equipment and facilities, quality interfaces, automation, and the business decisions that keep those systems coherent.
BiOS exists to bring that systems lens to emerging companies that need clarity more than another open-ended retainer.
Contact
Start with a short conversation.
Tell me where you are in the scale-up journey. If the assessment is a fit, we’ll scope it clearly before anything begins.