20 Years of Biotech Leadership
- ◆MSAT and process development leader with multiple successful clinical GMP manufacturing campaigns across high-performing teams and CDMO partners
- ◆Technology transfer specialist for conventional and novel manufacturing platforms, ensuring robust, scalable, and compliant processes
- ◆End-to-end unit operation expertise from upstream cell culture through drug product fill-finish across mAb, ADC, viral vector, and microbial platforms
- ◆QbD-driven characterization, process control strategies, and CPV to guide tech transfer, scale-up, and process validation
- ◆CMC regulatory content author (IND/IMPD/BLA) with drug product expertise in aseptic processing, RABS/isolator technologies, lyophilization, and sterile formulation
- ◆AI integration pioneer building next-generation tools for biopharma process engineering
Areas of Expertise
Upstream Processing
- mAb/Peptibody Production
- Mammalian & Microbial Systems
- Cell Culture Optimization
- Bioreactor Scale-up
Downstream Processing
- UF/DF Operations
- Harvest & Formulation
- Purification Strategies
- Process Intensification
Drug Product & Fill-Finish
- Aseptic Vial/Syringe Filling
- RABS & Isolator Technology
- Lyophilization & Formulation
- Sterile Filtration (TFF)
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
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 (UF/DF/TFF), 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
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.
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.
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.
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.
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.
AI Innovation in Biopharma
My drive to continuously grow and explore emerging technologies led me to formally study AI in biopharma—not just as an academic pursuit, but as a way to push the boundaries of what's possible in our industry. Beyond core responsibilities as Principal Engineer at Elevation Oncology, I took the initiative to integrate AI across business and scientific functions.
These efforts resulted in enhanced efficiency, data-driven decision-making, and significant operational improvements while maintaining scientific rigor and compliance.
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.
Technical Architecture Progress
Live snapshot of what is built, what is in flight, and what is next.
Monorepo shell, demo pages, API wiring, and UX polish.
Monte Carlo, DoE analytics, PFD editing, scenario library.
RBAC, audit trail automation, e-signatures, validation packs.
Regulatory co-pilot expansion, CoA parsing, doc generation.
Performance hardening and case-study narratives.
Worktree highlights
Editable equipment list, API save/load, and summary exports.
Shared save/load across Monte Carlo and DoE demos.
Keyword search, tag filters, and live-only toggle.
Back diagrams by Postgres and add auth gating.