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Lab Automation · High-Throughput Workcells · Data Foundry · CMC Scale-Up
From Process Intent to Machine Control — 20+ Years Bridging CMC and Lab Automation
- ◆Independent consultant and platform builder who pairs deep bioprocess / CMC scale-up experience with hands-on lab automation — so workcells, skids, and data pipelines are designed for the real chemistry, safety envelope, and operational scale, not just the code.
- ◆Translates complex bioprocess control narratives into executable PLC logic (Ladder Logic / Structured Text) for industrial-scale skids and precision lab environments.
- ◆Designs and troubleshoots hardware interlocks, I/O mapping, sensor networks, and edge device relays for fail-safe physical operations — robust hardware integration from deck to plant floor.
- ◆Bridges low-level device control (PLCs, liquid handlers, high-throughput workcells) with high-level data orchestration (LIMS, ELN, automated sample tracking, and continuous data connectivity into analytics / data foundry paths).
- ◆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.
- ◆Holistic viral-vector and vaccine process experience — HEK293 cell culture and adenoviral manufacturing from transfection and infection through harvest, downstream purification, and scaled-down characterization models.
- ◆Tech transfer and global CDMO oversight — 15+ tech transfers with on-floor PiP support and remote governance, applying QbD, control strategies, and CPV from scale-up through commercialization; CMC dossier authoring (IND/IMPD/BLA/PMDA) with aseptic DP depth where fill-finish meets automated lines.
Areas of Expertise
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
MSAT & Tech Transfer
- QbD & Process Characterization
- CPP/CQA Mapping & Control Strategy
- Scale-up intent → executable control strategy
- Process Validation (PPQ/CPV)
Advanced Modalities
- AdV Vectors
- ADC Conjugation
- Chemical Synthesis
- Novel Platform Transfer
Regulatory & CMC Submissions
- IND/IMPD/BLA/NDA Authoring
- CTD Module 3 Content
- Agency Responses (FDA/EMA)
- Audit Preparation & Support
Lab Automation & Control Systems
- High-throughput workcells & precision liquid handling
- PLC logic (Ladder Logic / Structured Text) for skids & lab
- Hardware interlocks, I/O mapping & sensor networks
- Device ↔ LIMS / ELN / data foundry orchestration
- Lab → OT → analytics digital stack (SPC/CPV deep-links)
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
From Process Intent to Machine Control
Automation that accelerates scientific delivery starts with process fluency. I take the same control narratives used in CMC scale-up and validation — CPPs, interlocks, sampling plans, fail-safe states — and make them executable on hardware: PLC logic on skids, deck protocols on liquid handlers, and structured payloads into LIMS/ELN and data foundry pipelines.
Scientific intent → PLC logic
Convert unit-operation and safety requirements into Ladder Logic / Structured Text sequences that operators and CQV teams can verify — industrial skids and precision lab controllers alike.
Robust hardware integration
Design and troubleshoot hardware interlocks, I/O maps, sensor networks, and edge relays so physical failure modes fail safe before software ever sees a happy path.
Device control ↔ data foundry
Connect PLCs and liquid handlers to LIMS/ELN sample tracking and automated data pipelines so continuous data connectivity is part of the method, not a spreadsheet afterthought.
Operating Model: External Manufacturing Delivery
I pair CMC and automation depth with a delivery system that keeps programs on track across external partners and internal workcells—clear decision cadence, measurable performance, inspection-ready documentation, and control logic that matches the process on the floor.
CDMO site leadership
Lifecycle ownership across decide/select/transfer/manage/exit with crisp responsibilities and escalation paths.
Dashboards & execution cadence
KPI reporting, schedule risk visibility, and a predictable operating rhythm for Joint Project Teams.
GxP documentation discipline
Document control patterns: storage, archival, retention, access, and evidence-first readiness.
Risk & issue management
Risk registers, issue logs, decision logs, and mitigation tracking tied to program milestones.
Process Validation Across the Lifecycle
I run risk-based validation as a connected lifecycle, not a box-checking exercise. Stage 1 design and characterization on qualified scaled-down models, Stage 2 performance qualification (PPQ), and Stage 3 continued process verification (CPV) — but the value is in how 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
A lifecycle, not a checklist
5+
PPQ / validation programs led
Cpk ≥ 1.33
Capability targets that anchor PPQ acceptance
That same lifecycle thinking extends into lab and process automation: recipe steps, hardware interlocks, and data lineage are treated as part of the control strategy — with models and tools (this platform included) that accelerate characterization, trending, and documentation without compromising GxP discipline.
Drug Product & Aseptic Processing
Alongside deep drug substance experience, I bring strong drug product capabilities spanning sterile process design, aseptic fill-finish operations, lyophilization, and formulation—with hands-on execution across clinical and commercial scales.
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 science meets machines: high-throughput workcells, control systems, and data orchestration. Formal AI training and hands-on hardware/software integration keep delivery methods sharp so scientific throughput improves without sacrificing rigor.
People & Culture
Beyond technical execution, I care about fostering healthy, motivated teams and contributing to a culture where people feel valued and empowered. Success is built on shared values and ethical decision-making.
Scientific Excellence
Commitment to rigorous science, data integrity, and compliance is non-negotiable. Every project is approached with the same dedication to quality and attention to detail that patients deserve.
Patient-Focused Innovation
At the heart of every process improvement and technical innovation is the goal of delivering life-changing treatments to patients who need them most.
About This Platform
BioProcess Nexus demonstrates the convergence of bioprocess engineering with lab automation and modern software. It is built for real CMC and scientific-operations challenges — showing how domain knowledge, robust hardware integration, and disciplined software design accelerate scientific delivery under GxP expectations.
As a Tool
Interactive planners and simulators for workcells and data pipelines, process control rooms, Monte Carlo supply forecasting, Design of Experiments, and AI-assisted regulatory intelligence — with synthetic demo data clearly labeled.
As a Portfolio
Evidence of architecting compliant, production-grade solutions for biopharma scientific operations: high-throughput workcell planning, LIMS/ELN-oriented payloads, PLC-aware control narratives, and CMC case studies on one stack.
This Platform, as a Working Portfolio
BioProcess Nexus is my interactive portfolio — engineering tools and case studies that put real CMC and automation reasoning on screen. End-to-end spines include GLP-1 peptide TFF scale-up, a validation-forward ChAd adenoviral vaccine lifecycle, and a Digital Automation stack from lab systems through process OT and data foundation — plus an Interactive High-Throughput Workcell Planner for hiring managers and collaborators evaluating lab automation fit.
USP & DSP Control Rooms
Upstream (seed → infection → harvest) and downstream (TFF/UF-DF) simulators with integrated yield, CPP windows, and a live harvest handoff.
Validation-forward case studies
ChAd adenoviral and GLP-1 playbooks mapped to the FDA Stage 1–3 lifecycle, FMEA risk, PPQ readiness, and CPV.
Lab Automation & Workcell Planner
High-throughput workcell configuration, payload simulation to LIMS/ELN / data foundry paths, and multi-layer scripting hooks (Python, C#, Ladder Logic / Structured Text).
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.
Let's Connect
Looking for someone who bridges bioprocess scale-up with executable lab automation — workcells, control systems, and data foundry connectivity — while staying grounded in people, culture, and patient-focused innovation? Let's discuss how we can accelerate scientific delivery together.