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AI Enablement · Manufacturing Operations · Clinical Supply · Digital CMC
20+ Years in Life Sciences Manufacturing, Applied to Everyday AI
- ◆Independent consultant and platform builder who pairs CMC and manufacturing operations experience with applied AI and automation, so digital solutions fit the process, quality system, and plant floor.
- ◆Partners with manufacturing, MSAT, Clinical Operations, Quality, Regulatory, and business stakeholders to turn operational and supply challenges into defined AI and automation use cases, solution concepts, and ROI, then works with developers and platform owners to get them adopted.
- ◆Hands-on digital platforms, data pipelines, and intelligent workflows across historian-connected OT, LIMS/ELN, IRT-linked supply models, and Azure-based generative / agentic tools that improved cost, speed, and decision quality.
- ◆Change leader for AI literacy and adoption: playbooks, demos, training, and citizen-developer guardrails so new tools become how work gets done.
- ◆Clinical supply and Technical Operations across DS, DP, and IMP: study-level forecasting, IRT/RTSM-linked planning, packaging, labeling, and global distribution, with CDMO/CRO oversight that keeps depots, sites, and manufacturing on one plan.
- ◆Process validation depth: 5+ PPQ / validation programs and risk-based (FMEA) strategies across 20+ DS/DP processes, aligned to the FDA Stage 1–3 lifecycle, ICH Q8–Q11, and 21 CFR Part 11.
- ◆Viral-vector and vaccine process experience: adenoviral and multi-host manufacturing from culture through harvest, purification, and characterization, treated as a reusable platform capability.
- ◆Tech transfer and global CDMO oversight: 15+ tech transfers with on-floor and remote governance, applying QbD, control strategies, and CPV from scale-up through commercialization; CMC dossier authoring (IND/IMPD/BLA/PMDA), including packaging, labeling, and distribution content, with aseptic DP depth where fill-finish meets automated lines.
Areas of Expertise
Applied AI & Manufacturing Systems
- Generative AI, agentic workflows, and intelligent automation
- OT/IT connectivity: LIMS, historians, MES/EAM, digital twins
- Demand generation, use-case definition, and ROI
- Enablement, training, and adoption playbooks
- Lab-to-plant automation as one layer of the stack
Clinical Supply & Technical Operations
- DS/DP forecasting and study-level supply plans
- IRT/RTSM planning, pack/label, and IMP distribution
- Depot/site inventory, resupply, and reconciliation
- CDMO/CRO contracting, SOWs, and performance
- Scenario planning and Monte Carlo stockout risk
MSAT & Tech Transfer
- QbD & Process Characterization
- CPP/CQA Mapping & Control Strategy
- Scale-up intent → executable control strategy
- Process Validation (PPQ/CPV)
Upstream Processing
- mAb/Peptibody Production
- Viral Vector & Vaccine Production
- Mammalian & Microbial Systems
- Cell Culture Optimization
- Bioreactor Scale-up
Downstream Processing
- Tangential Flow Filtration (TFF)
- UF/DF Operations
- Harvest & Formulation
- Purification Strategies
- Process Intensification
Drug Product & Fill-Finish
- Aseptic Vial/Syringe Filling
- RABS & Isolator Technology
- Lyophilization & Formulation
- Sterile Filtration
Advanced Modalities
- AdV Vectors
- ADC Conjugation
- Chemical Synthesis
- Novel Platform Transfer
Regulatory & CMC Submissions
- IND/IMPD/BLA/NDA Authoring
- Packaging, labeling, and distribution CMC
- CTD Module 3 Content
- Agency Responses (FDA/EMA)
- Audit Preparation & Support
Technical Writing & Documentation
- Batch Records & MBRs
- SOPs & Technical Reports
- Risk Assessments (FMEA)
- Deviation Investigations (NC/CAPA)
Leadership & Culture
- Team Development
- Cross-functional Collaboration
- Ethical Decision-Making
- Patient-Focused Innovation
Program Delivery & Vendor Oversight
- Contracts, MSAs, SOWs, and quality agreements
- Timelines, critical path, and budget tracking
- Operational dashboards and spend visibility
- FMEA-based supply and operational risk
Applied AI in Manufacturing Operations
Useful manufacturing AI starts with process fluency. I take the same operational narratives used in CMC scale-up and validation (CPPs, sampling plans, fail-safe states, data lineage) and turn them into generative AI, RPA, and workflows that operations teams can run, in partnership with the teams who own the platforms.
Discovery → use cases
Facilitate process reviews with sites and value streams; shape an actionable demand pipeline with solution concepts and ROI that match operational and clinical-supply priorities.
Delivery partnership
Work with IT, automation, and platform owners on RPA, generative AI, and agentic solutions that are scalable, maintainable, and ready for enterprise governance.
Enablement & value
Training, playbooks, citizen-developer guardrails, and adoption metrics so AI becomes part of daily operations.
Operating Model: External Manufacturing & Clinical Supply
I pair CMC and applied-AI depth with a delivery system that keeps programs on track across manufacturing sites, clinical supply, and external partners: clear decision cadence, measurable performance, inspection-ready documentation, and digital workflows that match how the plant and the study run.
CDMO site leadership
Lifecycle ownership across decide/select/transfer/manage/exit, including SOWs, quality agreements, and vendor performance against scientific, quality, timeline, and budget standards.
Dashboards & execution cadence
KPI reporting for manufacturing, inventory, and spend versus plan, with schedule risk visibility and a predictable operating rhythm for Joint Project Teams.
GxP documentation discipline
Document control patterns plus supply-chain SOPs, IRT specifications, and pack/label/distribution evidence that hold up in audits.
Risk & issue management
FMEA-based risk registers, issue and decision logs, and scenario planning that stress-tests forecasts before stockouts or excess inventory hit the clinic.
Clinical Supply Models
Career work on study-level forecasting, IRT/RTSM, pack/label, and IMP reconciliation informs how I think about clinical supply. The interactive tools on this platform currently model the planning layer: aggregate demand, inventory position, manufacturing lead time, and batch-yield uncertainty, with Monte Carlo scenarios for stockout and surplus risk. A CDMO dashboard and risk/PM views cover KPI and demo-project oversight alongside that forecast.
The Monte Carlo supply forecast and PM & scope control suite below are live public previews — open without sign-in. Workspace inventory and other Access Required suites stay invite-only.
Demand, inventory, and lead time
Set aggregate demand, starting inventory, and lead-time assumptions, then see how buffers hold as manufacturing replenishes stock.
Batch yield and Monte Carlo risk
Vary batch-yield mean and spread, then run Monte Carlo trajectories to quantify stockout and surplus risk under uncertain replenishment.
CDMO and program oversight
Demo CDMO dashboards surface KPIs, projects, and recent batches; risk and PM views sit alongside for FMEA-style and timeline context.
Process Validation Across the Lifecycle
I run risk-based validation as a connected lifecycle. Stage 1 design and characterization on qualified scaled-down models, Stage 2 performance qualification (PPQ), and Stage 3 continued process verification (CPV) are useful because the stages link. FMEA criticality feeds the CPP/CQA control strategy, and statistically grounded sampling plans (tolerance intervals, capability targets, and power-based lot counts) make PPQ outcomes predictable before a single conformance lot runs.
Stage 1–3
Connected Stage 1–3 lifecycle
5+
PPQ / validation programs led
Cpk ≥ 1.33
Capability targets that anchor PPQ acceptance
That same lifecycle thinking extends into OT, historians, and AI-enabled CPV: recipe steps, data lineage, and adoption metrics are treated as part of the control strategy. Models and tools (this platform included) accelerate characterization, trending, and documentation under GxP discipline.
Drug Product & Aseptic Processing
Alongside drug substance experience, I bring drug product capabilities in sterile process design, aseptic fill-finish, lyophilization, and formulation, with hands-on execution across clinical and commercial scales. Pack/label and IMP distribution sit with that work when the study depends on the lot leaving the plant on time.
Aseptic Fill-Finish & Sterility Assurance
Vial and syringe filling on automated lines (Bosch Syntegon, Vanrx), media fills, smoke studies, environmental monitoring, and pressure cascade controls within RABS/isolator and ISO 5/7 cleanroom environments.
Lyophilization & Formulation
Freeze-drying cycle development and optimization, sterile filtration and bioburden control for drug product, formulation characterization, and stability assessment for biologics including mAb, ADC, and peptide modalities.
Cap/OpEx Project Delivery
Full-lifecycle ownership of facility and equipment build-outs: URS authoring, design review, procurement, FAT/SAT, installation, commissioning, IQ/OQ/PQ, and operational turnover. Track record on $100M+ in combined projects.
CQV & Process Validation
Commissioning, qualification, and validation of filling lines, RABS/isolators, lyophilizers, BSCs, CIP/SIP systems, and formulation skids. Authored and approved validation protocols and reports to cGMP standards.
Select Aseptic Cap/OpEx Projects
Elevation Oncology$25M+
Bosch Syntegon RABS
Due diligence on commercial-scale RABS design with CDMOs/EPCs; reviewed RC/CAPAs; ensured cGMP/FDA/EMA alignment for mAb and ADC drug product.
ImmunityBio$25M+
GMP Suites & Vanrx Lines
Adapted clinical cGMP production suites to new platforms; authored equipment URS; evaluated and procured 10+ Vanrx fill lines and RABS systems.
Rezolute Bio$20M+
ISO 5 RABS & New cGMP Facility
Managed glove-box RABS build-out in ISO 5 for DP activities; led aseptic processing, EM programs, and equipment CQV through IQ/OQ/PQ.
Amgen$35M+
Pilot & Commercial Operations
Custom RABS/ISO 5 with active air for roller bottle machine; UVC media treatment skid design/build; cleaning validation and BSC capabilities.
Combined project value exceeds $100M across aseptic, CQV, and facility build-out initiatives.
Philosophy & Values
Continuous Learning
Stay current where manufacturing meets applied AI: LLMs, agentic workflows, RPA, and OT/IT connectivity. Formal AI training and hands-on delivery keep enablement practical so operations teams can use new tools without sacrificing GxP rigor.
People & Culture
Technical execution matters, and so do the teams who run it. I work to keep groups motivated and valued. Success depends on shared values and ethical decisions.
Scientific Excellence
Rigorous science, data integrity, and compliance are the baseline. Every project gets the same attention to quality that the product requires.
Patient-Focused Innovation
Process improvements and technical work exist to get treatments to patients reliably, including uninterrupted clinical supply.
About This Platform
BioProcess Nexus shows how bioprocess engineering meets applied AI and manufacturing digitalization. It is built for CMC and operations work: domain knowledge, workflows, and disciplined software design under GxP expectations.
As a Tool
Interactive playbooks and simulators for process control rooms, OT historian streams, Monte Carlo clinical supply forecasting, Design of Experiments, and AI-assisted regulatory intelligence. Synthetic demo data is labeled.
As a Portfolio
Evidence of architecting GxP-aware, AI-enabled solutions for life sciences manufacturing: supply-chain models as a core CMC and program-management component, digital twins and OT connectors, LIMS/ELN-oriented payloads, enablement playbooks, and CMC case studies on one stack.
Portfolio links below stay on public hubs, live public previews, guided tours, or screenshot walkthroughs — not Access Required tool walls.
This Platform, as a Working Portfolio
BioProcess Nexus is my interactive portfolio: engineering tools and case studies that put CMC, clinical supply, and AI-enabled operations reasoning on screen. End-to-end spines include GLP-1 peptide TFF scale-up, a validation-forward ChAd adenoviral vaccine lifecycle, Monte Carlo supply models tied to program timelines, and a Digital Automation stack from data foundation through process OT. A workcell planner is available when lab-systems integration is the question.
USP & DSP Control Rooms
Upstream (seed → infection → harvest) and downstream (TFF/UF-DF) simulators with integrated yield, CPP windows, and a live harvest handoff.
Clinical supply models
Monte Carlo demand and inventory risk from aggregate demand, lead time, and batch-yield inputs, plus a CDMO dashboard for KPIs, projects, and recent batches (demo project oversight).
Validation-forward case studies
ChAd adenoviral and GLP-1 playbooks mapped to the FDA Stage 1–3 lifecycle, FMEA risk, PPQ readiness, and CPV.
Digital Automation & OT
Live OT connectors, predictive insights, CPV/SPC deep-links, and enablement playbooks, plus a workcell planner when the lab-systems layer is in scope.
Program command center
Save-to-project artifacts roll up into a milestone timeline, budget, and CQV/PPQ readiness, with a Part 11-style audit trail.
Case studies, guided tours, and the supply/PM previews below are open without sign-in. Workspace inventory and other Access Required suites stay invite-only.