About
Summary
Pharmaceutical formulation scientist with 8+ years of industry experience and 7 years of
academic research, specializing in injectable formulations and advanced drug delivery
systems. Dual-track expertise includes infusion and parenteral formulations for small
molecules and medical devices, as well as nanoparticle-based systems such as lipid
nanoparticles (LNPs) for mRNA, pDNA, and siRNA, and polymeric (PLGA) or inorganic
nanoparticles for targeted small molecule delivery. Skilled in CMC documentation, GMPcompliant development, and cross-functional project execution. Experienced in international,
interdisciplinary collaboration across R&D, regulatory, and manufacturing functions. Near
completion of a PhD focused on polymeric nanoparticle-based drug delivery, while working
full-time in industry.
Positions
R&D Specialist – LNP / Liposomes Scientist Feb 2024 -
Prepared 500+ LNP formulations (mRNA/siRNA) using Spark and Ignite
(Precision Nanosystems).
Designed and developed technology of pDNA compactisation and
encapsulation into LNP.
Designed an efficient ionizable lipid screening algorithm that improved
nanoparticle characteristics and streamlined development.
Evaluated >20 ionizable lipids for nanoparticle formation, stability, and
encapsulation performance.
Demonstrated advanced understanding of lipid structure–activity
relationships in LNP design.
Biotechnologist Apr 2018 - Sep 2019
Designed lipid nanoparticles (LNPs) for targeted mRNA delivery into
hepatocytes.
Built an in silico library of 40+ ionizable lipids for internal screening.
Co-led scientific planning of a gene therapy project based on mRNA-loaded
LNPs for genetic disorder treatment.
Product Formulation Manager Feb 2016 - Apr 2018
Led formulation assessment of 20+ new product concepts, evaluating safety,
stability, manufacturability, and market fit.
Contributed to the development of 15+ new formulations for medical and
cosmetic use.
Advised executive team on formulation feasibility and innovation potential in
high-level strategic meetings.
Collaborated with marketing on product positioning, technical content, and
regulatory-justified claims.
Formulation Scientist / CMC Specialist Jul 2013 - Feb 2016
Developed and optimized 10+ sterile parenteral and hyaluronic acid–based
products from early to late-stage
Conducted stability studies, container closure evaluations, terminal
sterilization, and scale-up activities
Developed technology of hyaluronic-acid crosslinking for cosmetic use
Created a stabe and effective combination of hyaluronic acid with
decametoxine, based on which many products were developed
Led the development of a hemostatic agent for military use, optimized for
rapid clotting and field stability, and deployed in combat emergency care
settings
Authored CMC (Module 3) and GMP-compliant SOPs; supported Regulatory
Affairs with dossier preparation and authority responses
Collaborated cross-functionally with QA, RA, manufacturing and R&D teams
Research Scientist Sep 2010 - Jun 2013
Institute of Molecular Biology and Genetics
Led a 3-year academic project on HA-coated CoFe₂O₄ nanoparticles for
targeted cancer cell therapy
Designed the research plan, managed laboratory setup and procurement
Performed in vitro and in vivo experiments to assess therapeutic efficacy and
toxicity of nanoformulations
Education
Faculty of Pharmacy, Charles University (Hradec Králové, Czech Republic) 2019 -
Field of study: Pharmaceutical Technology
Degree: PhD
Dissertation: Development of PLGA nanoparticles for targeted delivery of
obeticholic acid.
Designed and optimized PLGA nanoparticles with controlled size, enhanced
EE%, and sustained-release profiles
Developed and validated analytical methods (UV-Vis, HPLC) for drug
quantification
Conducted in vitro testing for cytotoxicity and delivery efficacy
Awarded GAUK grant for doctoral research
Supervised diploma students as a research consultant
Taras Shevchenko National University of Kyiv, Ukraine 2013 - 2015
Field of study: Biochemistry
Degree: MSc
Taras Shevchenko National University of Kyiv, Ukraine 2009 - 2013
Field of study: Biology
Degree: BSc
Skills
Pharmaceutical & Formulation Development
Formulation development for parenteral injectable liquids, nanosuspensions, and gel-/powder-based products across early and late-stage development.
Reformulation to address stability, solubility, or performance issues.
Application of solubility enhancement techniques tailored to API properties: pH-shift, co-solvents, surfactants.
Rational excipient selection aligned with Ph. Eur. and FDA IIG guidelines for safety and compatibility.
Buffer system engineering with precise control of pH, osmolality, and cryoprotectant selection and optimization.
Process development for lyophilization and terminal sterilization.
Assessment of container closure compatibility to ensure formulation stability, sterility, and packaging integrity.
Technology transfer and GMP scale-up of lab-developed formulations to pilot and production scale.
Comprehensive ICH-compliant stability profiling, including forced degradation and photostress testing.
Nanotechnology & Drug Delivery
Lipid-based, polymeric, and inorganic nanoparticle systems for delivery of nucleic acids and small molecules.
Lipid nanoparticles formulation development and optimization for mRNA and plasmid DNA (pDNA) delivery.
LNP formulation optimization: lipid composition, N/P ratio adjustment and PEG-lipid content tuning.
Polymeric nanoparticle preparation via nanoprecipitation, emulsion-solvent evaporation, and double emulsion techniques
Encapsulation strategy selection for small molecules and release profile evaluation from polymeric nanoparticles
Surface modification and ligand selection for targeted delivery applications
Hands-on expertise with Precision Nanosystems Spark and Ignite for reproducible LNP manufacturing
Analytical & Bioanalytical Techniques
Physicochemical methods: DLS, zeta potential, osmolality, UV-Vis spectroscopy, HPLC
Nucleic acid quantification and purity assessment: RiboGreen, PicoGreen, gel electrophoresis
Biophysical techniques: Microscale Thermophoresis (MST), fluorescence microscopy
Rheological analysis: viscometry, rheometry
Cell-based assays: cytotoxicity (LDH), proliferation (MTT, MTS), genotoxicity assays
Cell culture: mammalian cell lines and primary cell isolation, expansion, and maintenance
Instrumentation & Platforms
Precision Nanosystems Spark and Ignite — scalable LNP manufacturing
Stunner (Unchained Labs) — UV-Vis, DLS, concentration analysis
Zetasizer (Malvern) — particle size and zeta potential
Microscale Thermophoresis (MST) — binding affinity and molecular interaction
Varioskan (Thermo Scientific) — multimode microplate reader
Nanodrop — nucleic acid/protein quantification
Optical and fluorescent microscope
HPLC systems (Agilent)
Regulatory Knowledge & Documentation
Preparation and review of CMC documentation, including CTD Module 3 (3.2.P.1–3.2.P.8)
Knowledge of ICH, EMA, and FDA regulatory expectations for drug product development
Familiarity with Ph. Eur., USP, BP standards for excipients and analytical methods
Work experience in GMP-compliant environments, including SOPs, batch records, deviation reporting
Basic patent search and competitive landscape analysis to support formulation strategy
Project & Process Management
Planning and coordination of experimental workflows, material sourcing, and documentation
Use of Gantt charts, Kanban boards, Excel, and Notion for multi-project tracking
Maintenance of internal reports, method summaries, and decision-supporting data files
Agile adjustment of project timelines in response to delays, results, or resource constraints
Experience managing multiple concurrent R&D projects in fast-paced environments
Cross-functional collaboration with QA, RA, and manufacturing teams to align development with quality and regulatory standards
Professional interests
Nanotechnology and targeted drug delivery, formulation development, R&D, oncology
Keywords: gene therapy, Oncology, targeted deliveryCV
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