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ArtProtein Biologics CDMO
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Expert Biologics Consulting

Senior-level biologics expertise,
without the full-time overhead.

20+ years in CHO/HEK upstream development, GMP tech transfer, CMC regulatory filings, and process economics. Available for advisory engagements, workshops, and fractional R&D leadership — for the teams who need a seasoned expert, not another generalist.

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20+
Years in biologics R&D
>80%
Process cost reduction achieved
20+
CMOs screened & evaluated
5
Global CDMO partnerships managed
Ideal clients

Who I work with

I work best with early-to-mid stage biotech teams who need hands-on expert guidance — not project management theater — at a critical inflection point.

Series A / B biotech founders

Need CMC strategy and CDMO selection expertise before committing to a GMP partner.

Teams approaching USDA 9CFR submission

Need a seasoned CMC author and regulatory strategist with direct 9CFR experience.

CHO/HEK programs at platform crossroads

Stable vs. transient, scale-up strategy, or a process that isn't performing — I've seen it.

Process scientists learning DOE/JMP

Bioprocessing-specific DOE workshops for in-house R&D teams, CDMOs, and biotech companies.

Startups preparing for GMP tech transfer

Process descriptions, control strategies, and handover packages that actually survive due diligence.

Biotech boards seeking scientific credibility

Fractional R&D leadership and Scientific Advisory Board roles for investor-facing programs.

Consulting services

Three ways I can
accelerate your program

Each engagement is structured around your specific program, timelines, and gaps — not a generic retainer. Clear scope, defined deliverables, real accountability.

01
Highest demand

Bioprocess & CMC Strategy Consulting

End-to-end program strategy for antibodies and recombinant proteins in CHO and HEK systems. From platform selection and upstream process design through CMC documentation and USDA 9CFR regulatory submissions — I've done this at scale, not just advised on it.

  • CHO vs. HEK platform selection with written rationale and risk matrix
  • Upstream process development strategy (fed-batch, media/feed, DoE framework)
  • CDMO screening, evaluation scorecard, and selection recommendation (20+ CMOs evaluated)
  • CMC roadmap aligned to funding milestones and regulatory pathway
  • USDA 9CFR study plans, development summaries, and final report preparation
  • GMP tech transfer packages and process description documentation
Start a conversation →
Consulting rate
Contact for pricing →
Market demand
>80%
Process cost reduction achieved in past programs
>50%
Timeline reduction vs. industry baseline
5 global
CDMO partnerships managed end-to-end
02
Scalable · productizable

DOE/JMP Training & Statistical Consulting

The biologics industry has a chronic shortage of scientists who can actually apply Design of Experiments in a manufacturing context — not just run a textbook regression. I've trained scientists at Abbott, AstraZeneca, and Pfizer, run 7 industry workshops at JNU, and built QbD-aligned DoE programs for upstream and downstream bioprocessing.

  • Corporate DOE/JMP workshops (half-day, full-day, or 2-day) for biotech and pharma teams
  • QbD-aligned experimental design for upstream optimization and purification screening
  • Statistical analysis of existing process development data sets
  • Design Space definition and CPP/CQA identification aligned to CMC filings
  • Online course development for internal training or commercial licensing
  • Speaking engagements at CHI, BioPhorum, Pharma IQ, and similar conferences
Request a workshop quote →
Workshop pricing
Contact for pricing →
Market demand
7
Industry workshops delivered
8–12
Optimal team size per workshop
Peer-reviewed
Publication record in biologics R&D
Also available as
Conference keynotes
Online course licensing
Ongoing statistical retainer
Contact for pricing →
03
Long-term leverage

Fractional R&D Director & SAB Roles

For biotech companies that need senior scientific credibility without a full-time hire — and for investors who want a proven biologics expert sitting on the board. NIH postdoc pedigree, Abbott Laboratories R&D management experience, and regulatory filing track record make this a compelling profile for Series A/B scientific advisory needs.

  • Fractional R&D Director (5–10 hrs/month) for upstream platform strategy and oversight
  • Scientific Advisory Board membership with active technical guidance
  • Investor-facing scientific due diligence support and program narrative
  • Upstream strategy leadership for pre-IND or pre-BLA programs
  • Cross-functional alignment between R&D, CMC, and manufacturing teams
  • Cash + equity structures available for the right early-stage programs
Discuss a retainer →
Monthly retainer
Contact for pricing →
Market demand
NIH
Postdoctoral research background
R&D Mgr
Abbott Laboratories — biologics division
2–3
Concurrent SAB roles
Best for
$5M–$50M funded biotechs
Pre-IND / pre-BLA programs
Platforms needing upstream leadership
Defined engagements

Scoped consulting packages

Clearly defined scope, fixed deliverables, predictable cost. Ideal for teams that need to budget quickly and get moving without a lengthy SOW process.

Package 01
Program Rapid Review
A structured 1-week expert assessment of your current biologics program — what's working, what isn't, and what to address first.
  • Review of existing data, platform rationale, and CMC status
  • Written findings with prioritized risk flags
  • 30-min readout call with Q&A
  • Recommended next 90-day action plan
Delivery in 5–7 business days
Package 02 · Most requested
CMC Roadmap
A full CMC strategy document aligned to your molecule, funding timeline, and target regulatory pathway. The document you need before any CDMO conversation.
  • Platform selection rationale (CHO vs. HEK, stable vs. transient)
  • Development stage gate plan with decision criteria
  • CDMO fit assessment and RFP framework
  • CMC section outline aligned to target submission
  • Risk register with mitigation options
2–3 week engagement
Package 03
USDA 9CFR Study Design
For programs targeting USDA-regulated biologics. Experimental planning, study design, and report templates built to satisfy 9CFR requirements.
  • 9CFR-aligned experimental plan and study rationale
  • Report template with required sections pre-structured
  • Regulatory communication strategy
  • Review of existing development data for gaps
1–2 week engagement
Package 04
DOE/JMP Workshop
A tailored half-day or full-day Design of Experiments workshop for your R&D or process development team, applied to your actual biologics context.
  • Customized for CHO/HEK upstream or downstream context
  • JMP software exercises using real bioprocess case studies
  • QbD and Design Space concepts for CMC alignment
  • Post-workshop reference guide and templates
Delivered on-site or virtual
Background

Experience that speaks
for itself

  • NIH Postdoctoral Research Fellow
    National Institutes of Health — biologics R&D
  • R&D Manager — Biologics Division
    Abbott Laboratories · CHO/HEK upstream development
  • Peer-reviewed publications
    Biologics R&D — upstream process & CMC
  • 7 Industry Workshops Delivered
    DOE/JMP methodology for bioprocess scientists — JNU
  • 20+ CDMOs Screened & Evaluated
    Global CDMO landscape — selection & partnership management
  • USDA 9CFR Regulatory Experience
    Study designs, CMC submissions & development reports

Measured program impact

>80%
Reduction in process cost of goods through upstream optimization and CDMO selection strategy
>50%
Timeline reduction vs. industry baseline across CHO/HEK development programs
5 global
CDMO partnerships managed through GMP tech transfer and beyond
Engagement process

How an engagement works

1
Discovery call
30 minutes. You describe your molecule, program status, and key questions. Free of charge.
2
Scope proposal
A written engagement proposal with scope, deliverables, timeline, and cost — within 48 hours.
3
Engagement
We work together — calls, document reviews, data analysis, or workshop delivery per scope.
4
Deliverable
Clear written output you can use internally, with partners, and with regulators.

Ready to talk about
your program?

Describe your molecule, current stage, and the questions keeping you up at night. A senior scientist with matching experience will respond with a clear recommendation.

Start a conversation or Email directly