Profile
I'm a molecular virologist who became a CMC/TechOps operator. After ten-plus years inside gene therapy companies — building processes from bench through GMP, transferring them to CDMOs, and shepherding the resulting material into the clinic — I founded ViroSpark to do that same work for the developers who need it most: lean, early-stage teams whose first CMC decisions will define the next three years of their program.
I currently advise pre-seed academic spinouts through Series B companies on phase-appropriate CMC strategy, CDMO selection and oversight, process development, tech transfer, IND-ready technical documentation, and ex-US first-in-human pathway planning.
A large portion of what I do every week is network-driven matchmaking. I keep active relationships with CDMOs, process technology providers, and raw material suppliers across the gene therapy ecosystem — both in the US and ex-US. That gives me an honest, current read on what each one is actually good at, where they're investing, and where they fall short. The real value to a sponsor is understanding what the company needs, who can credibly deliver it, and how to structure the engagement so the right thing actually happens.
I've also been on both sides of the deal table — in company creation, out-licensing, and in-licensing diligence. That experience shapes how I work with founders and how I work with investors: I know what VCs and partners actually look for in a CMC package, what a credible capsid and process story sound like, and how to spot the technical risks that can quietly sink a deal.
"Early choices around process, partners, materials, and documentation can quietly set a gene therapy program back months. The job is to make those choices visible — and defensible — before they become expensive."
Experience
Founder & Principal — ViroSpark BioConsulting
2025 – Present · Boston / Remote
- Advise early-stage gene therapy teams on phase-appropriate CMC strategy across AAV, lentivirus, and engineered capsid programs.
- Lead CDMO selection, technical diligence, contract negotiation support, and ongoing oversight for sponsor clients.
- Author IND-supporting technical documentation: control strategies, comparability protocols, Module 3 sections, and tech transfer packages.
- Provide ex-US FIH pathway strategy, including IIT planning, IIT-to-IND bridging, and ex-US partner evaluation.
CMC & TechOps — Affinia Therapeutics
Prior role · Gene therapy / engineered AAV capsids
- Drove the CMC and TechOps function, owning the company's viral vector manufacturing strategy from research through IND-enabling and first GMP supply.
- Built and managed CDMO partnerships across upstream, downstream, fill/finish, and analytical testing.
- Owned Module 3 readiness, comparability strategy, and control strategy across multiple engineered capsid programs.
- Partnered cross-functionally with discovery, regulatory, quality, and clinical operations to sequence CMC against clinical milestones.
Ring Therapeutics (Flagship Pioneering)
Prior role · Novel viral vector platform / Flagship-founded company
- Contributed to viral vector process development and manufacturability strategy at a Flagship Pioneering-founded company building a novel viral vector platform.
- Worked across discovery-to-CMC handoffs in a fast-moving platform-creation environment.
Independent Consultant — VC & Technology-Developer Diligence
Ongoing · Investor-side & new-technology advisory
- Scientific due diligence for venture investors evaluating gene therapy and viral vector opportunities — capsid, process, and CMC risk assessment.
- Positioning and risk advisory for new-technology developers (process technology, analytical platforms, raw material innovators) bringing tools to the gene therapy market.
Earlier Industry Roles — Viral Vector Process Development & Manufacturing
Multiple roles spanning research, process development, and manufacturing operations
- Hands-on process development for AAV and lentiviral vector programs — upstream (HEK293 transient transfection, stable producer lines) and downstream (capture, polishing, full/empty separation).
- Tech transfer leadership from internal R&D into CDMO GMP environments.
- Analytical method development and qualification supporting release and stability.
Education
PhD, Molecular Virology
Doctoral research in molecular virology, with a focus on viral biology relevant to vector engineering and manufacturability.
Areas of Expertise
- AAV (natural serotypes & engineered/AI-designed capsids)
- Lentiviral vectors
- Transient transfection & stable producer cell line strategy
- Upstream & downstream process development
- Tech transfer (R&D → CDMO; CDMO ↔ CDMO)
- Phase-appropriate analytical control strategy
- Comparability for engineered capsids and process changes
- Module 3 / IND-supporting CMC documentation
- CDMO selection, RFP design, contracts, and oversight
- Ex-US FIH (IIT) pathway planning & bridging to US IND
- PPQ readiness & commercial-pathway planning
Selected Engagements
Representative ViroSpark engagements, anonymized to protect client confidentiality. Specifics and references available on request once we've established mutual fit.
A seed-stage biotech with a novel engineered AAV capsid had drifted off timeline: process yields lower than discovery models predicted, an unclear CDMO landscape, and plasmid sourcing that wasn't going to support tox or GMP supply.
ViroSpark defined the CMC path from RUO forward, ran a structured CDMO RFP and selection, sourced the right GMP plasmid partner, and identified the specific process fixes needed to get yields back into a manufacturable range.
Outcome: Program back on its original IND timeline, with a defensible CMC plan, a contracted CDMO, and qualified plasmid supply.
An academic spinout preparing to raise a seed round needed a credible CMC story for its data room — and an honest read on what its current process could (and couldn't) support.
ViroSpark delivered a focused diagnostic: a phase-appropriate CMC roadmap tied to clinical milestones, a prioritized risk register, and a defensible answer to "where's CMC?" for prospective investors.
Outcome: Investor-ready CMC narrative; clear sequencing of first-dollar CMC investment; identification of two process decisions that needed to be locked before tox.
A stealth seed-stage biotech using a wild-type AAV capsid needed a true 0-to-1 CMC build — from research-grade vector through plasmid decisions and into a defensible plan for GMP manufacturing across both US and ex-US plasmid supply and QC.
ViroSpark embedded as the de facto CMC lead and delivered:
- Plasmid sourcing & supply strategy — from research-grade vector through plasmid decisions, including US and ex-US plasmid manufacturing and QC.
- RUO RFP scoping — balancing process fit, scalability of the platform process, and risk of material use; defined analytical panels that allow manufacturability screens to occur at the right stages.
- CDMO engagement & assessment — evaluating partners against a flexible IND / Phase 1 path that balances cost, time, and risk.
Outcome: Ongoing longer-term engagement embedded with the team, with a coherent CMC plan that scales from research-grade vector through GMP supply.
A Series A gene therapy company running its first-in-human program ex-US needed to use ex-US Phase 1 material and clinical data as the foundation for a future US IND — without restarting the clock on process or manufacturing.
ViroSpark embedded with the team to navigate process development hands-on: adjusting process and manufacturing to be IND-ready under FDA expectations, working through cross-border CMC and regulatory differences, and designing the comparability and documentation framework that bridges ex-US Phase 1 material to a US program.
Outcome (in-flight): A path that preserves the speed advantage of ex-US FIH while delivering a process, package, and material set that will hold up as a US IND — without the costly do-over most ex-US programs encounter.
A Series B company had a backlog of documentation that needed to be drafted and finalized ahead of PPQ/PV. With the team focused on running the campaigns, technical writing was falling behind — creating real risk for both the PPQ runs and downstream regulatory questions.
ViroSpark took in documentation from early process and current GMP batches and executed across the full backlog — process development reports, history reports, process trending reports, and characterization reports — while flagging gaps and risks as they surfaced.
Outcome: Backlog cleared, with risks for PPQ runs and potential regulatory questions surfaced and documented — giving the team a defensible documentation foundation heading into PPQ/PV.
Network & Industry Reach
Active, ongoing relationships across the gene therapy manufacturing ecosystem — used in real time to match sponsors with the right partners for their modality, stage, and timeline.
- CDMOs — viral vector manufacturers across the US, EU, and APAC; transient and stable platforms; Phase 1 through commercial scale.
- Process technology providers — upstream bioreactor, downstream chromatography & TFF, fill/finish, and analytical instrumentation vendors.
- Raw material & GMP plasmid suppliers — including AAV helper systems, GMP plasmid producers, media, resins, and single-use components.
- Analytical specialists — capsid characterization, full/empty quantification, potency assay development, sequencing, and release testing.
- Ex-US clinical & IIT partners — sites and partners supporting ex-US first-in-human pathways with US-IND-bridgeable design.
- Industry forums — speaking and panel roles at the leading viral vector manufacturing summits (ASGCT, IHGT, PDA, viral vector PD & manufacturing summits).
Selected Speaking
Recent and upcoming engagements — see the full list on Insights.
- Panelist — "Manufacturing CGT for Rare Diseases: Navigating Speed, Cost & Risk." Gene Therapeutics Conference, 16–18 November 2026.
- Session Chair & Moderator — Viral Vector Manufacturing Stage, Advanced Therapies Conference 2026, 4–5 November 2026.
- Panelist — "Optimizing AAV Manufacturing at the Inflection Point: Engineering Breakthroughs, Analytical Reckoning, and the Road to Commercially Viable Gene Therapies." Cell & Gene Therapy Summit 2026, Boston, 6–8 July 2026.
- Panel Chair & Moderator — "Manufacturing and Supply Chain Strategies for Moving Fast Towards FIH." International Human Gene Therapy Conference, Boston, March 2026.
- Fireside Chat — "From Clinical Supply to Commercial Launch: Ensuring PPQ Readiness & BLA Success in Viral Vector Manufacturing." 4th Viral Vector Process Development & Manufacturing Summit, Boston, February 2026.
- Invited Speaker — "Unlocking Potential: The Promise of Transient Transfection for Viral Vector Production." Process Development & Viral Vector Manufacturing Summit, Boston, February 2025.
- Expert Panelist — Advancing AAV Manufacturing: Strategic Industry Discussion (2025).
