Stanislav Stan Khoruzhenko

About Stanislav Stan Khoruzhenko

Biopharma Leader | CMC Cell Culture & Cell Analytics | AI/ML Strategy, Decision Governance & Platform EnablementScientific leader with 25 years in biotechnology, integrating deep expertise in cell therapy/cell systems with modern AI/ML to improve CMC decision‑making and process outcomes. I operate at the intersection of biology, digital science, analytics, and enterprise decision processes, shaping how AI/ML is applied across CMC and ensuring models are built on the right data and used appropriately for process decisions.What I do:AI/ML strategy & decision governance (CMC): Define use cases, biological and analytical requirements, and decision governance for applying analytics and machine learning within CMC, with a current emphasis on PAT‑aligned analytics. Outcomes include process insights, cost and risk reduction, shortened process/product characterization cycles, and biomarker discovery using non‑invasive analytics through predictive ML models.Cross‑functional integration: Partner closely with Data Science, CMC Analytics, and Process Analytical Technology (PAT) to align modeling approaches, data standards, and analytical workflows with CMC needs, bridging scientific context with digital implementation.Multimodal, high‑dimensional data foundations: Lead strategies across conventional and spectral flow cytometry, imaging, and UV–Vis spectrometry to generate high‑dimensional, multimodal datasets that support predictive modeling, biomarker discovery, and mechanistic/process insights.Platform mindset: Drive platform and workflow designs that make complex biology computable, reproducible, and analytics‑ready across CMC, so insights can be trusted and scaled in development and manufacturing.Impact focusTranslate complex biology into model‑ready datasets that directly inform process understanding and decisions.Improve decision velocity in CMC by aligning analytics with cost, risk, and cycle‑time objectives.Ensure that AI/ML initiatives are governed, auditable, and fit‑for‑purpose for CMC processes.I am motivated by building the data and decision infrastructure that lets organizations apply AI/ML with confidence, turning complex biological signals into reliable, actionable insights for process development and manufacturing.

Experience

1. Senior Principal Scientist, Cell Culture Cell Therapy

   Bayer

   Jul 2022 — Present · Berkeley, CA, US

   Role retitled from Associate Director in February 2026 under Bayer’s North America scientific individual-contributor title redesign; scope and seniority unchanged.• AI/ML strategy & decision governance — Shape AI/ML adoption in CMC, including defining use cases, specifying requirements, and establishing decision governance aligned with PAT‑oriented analytics; represent Drug Substance Biologics priorities to support cost, risk, and cycle‑time objectives.• AI/ML enablement — Convert CMC cell culture questions into model-ready data and analytical workflows that improve process insight, reduce cost and risk, shorten characterization cycles, and enable predictive modeling from multimodal analytics.• Cross-functional integration — Align Data Science, Analytics, and Process Analytical Technology efforts with CMC biological context, data standards, and analytical requirements to enable fit-for-purpose modeling.• Multimodal, high‑dimensional data foundations — Lead strategies across conventional and spectral flow cytometry, imaging, and UV–Vis spectrometry to generate high‑dimensional, multimodal datasets supporting predictive modeling and mechanistic/process insights.• Innovation with measurable business impact — Sole inventor of a new media formulation that reduced reliance on a key growth factor, achieving ~70% cost savings potential.• Workflow design for scaled experimentation — Designed a semi‑automated incubator workflow for media development to increase comparability, throughput, and reproducibility in support of process optimization.• Enterprise scientific influence — Shape technology evaluations and adoption discussions within Bayer’s global Flow Cytometry and Imaging expert communities, advancing analytics and AI practices across CMC.• Team leadership in process characterization — Lead project‑based lab teams (up to 5 scientists) on process characterization campaigns, generating decision‑relevant datasets.

Education

• The Johns Hopkins University School of Medicine

  Postdoctoral fellowship training certificate, Immunopathology

• Ivanovo State Medical University (IvSMU)

  M.D., Adult Medical Care

• McDaniel College

  B.A., Biochemistry and Biology

• Ivanovo State Medical University (IvSMU)

  Certification in Internal Diseases

• The Johns Hopkins University

  M.S., Biotechnology

Skills

• Real-Time Polymerase Chain Reaction (Qpcr)
• Tissue Culture
• Protein Chemistry
• Protein Purification
• Cell Culture
• Elisa
• Snp Genotyping
• Mouse Handling
• Protein Expression
• Cell Based Assays
• Real-Time Pcr
• Microarray Analysis
• Immunology
• Dna Extraction
• Multi-Color Flow Cytometry
• Sds-Page
• Immunoassays
• Facs Analysis
• Electrophoresis
• Rna Isolation
• Qpcr
• Fluorescence Spectroscopy
• Gel Electrophoresis
• Animal Models
• Science
• Flow Cytometry
• Hplc
• Mouse Models
• Biacore
• Antibodies
• T Cells
• Chromatography
• Cell Biology
• Surface Plasmon Resonance
• Biochemistry
• Flowrna
• Cell
• In Vivo
• Transfection
• Car T Cells