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CMC Process Engineering · Process Validation · Tech Transfer · Digital Tools
20+ Years in Vaccine & Biologics CMC
- ◆Independent CMC consultant partnering with biotech and CDMO teams across the process lifecycle — from characterization and scale-up through validation and commercial support
- ◆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
- ◆End-to-end (upstream → downstream → fill-finish) unit-operation expertise across viral vector, mAb, ADC, peptide, and microbial platforms — early stage through commercial
- ◆Tech transfer and global CDMO oversight specialist — 15+ tech transfers with on-floor PiP support and remote governance, applying QbD, control strategies, and CPV from scale-up through commercialization
- ◆CMC dossier author (IND/IMPD/BLA/PMDA) with drug-product depth in aseptic processing, RABS/isolator technologies, lyophilization, and sterile formulation; clear, inspection-ready validation documents
- ◆Pragmatic adopter of AI/automation — builds models, agents, and tools (like this platform) that accelerate process and data analysis while preserving GxP rigor
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 & Comparability
- 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
AI & Automation
- Predictive Modeling
- Workflow Automation
- Data-Driven Optimization
- Cost Reduction (40-90%)
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
Operating Model: External Manufacturing Delivery
I pair technical depth in CMC with a delivery system that keeps programs on track across external partners—clear decision cadence, measurable performance, and inspection-ready documentation.
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
I pair that rigor with pragmatic AI/automation — building the models, agents, and tools (this platform included) that speed up 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
I believe in staying at the forefront of emerging technologies and methodologies. Formal AI training and hands-on integration demonstrate a commitment to pushing boundaries and delivering innovative solutions.
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
This platform demonstrates the convergence of bioprocess engineering expertise with modern software development. Built to address real CMC challenges, it showcases how AI-assisted development can bridge the gap between domain knowledge and technical implementation.
As a Tool
Functional capabilities for Monte Carlo supply forecasting, Design of Experiments, and AI-powered regulatory intelligence.
As a Portfolio
Demonstrates ability to architect compliant, production-grade solutions for the biopharma industry with modern tech stack.
This Platform, as a Working Portfolio
BioProcess Nexus is my interactive portfolio — engineering tools and case studies that put real CMC reasoning on screen. Two end-to-end case studies anchor it: a GLP-1 peptide TFF scale-up and a validation-forward ChAd adenoviral vaccine lifecycle, each linking upstream and downstream control rooms into a program record.
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.
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.