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Hire Dr. Nikolaos D.

United Kingdom

USD 70 /hr

Analytical Development & CMC Consultant | PhD Biochemist | Method Validation, Potency Assay & Regulatory Compliance Expe

Profile Summary

I am an Analytical Development Scientist and Biochemist (PhD in Drug Delivery & Microbiology) with over a decade of experience in biologics, cell & gene therapy and advanced therapy medicinal products (ATMPs). My expertise spans analytical method development, validation, comparability studies and CMC documentation in alignment with EMA/FDA and ICH regulatory standards. I have served as Molecular Biology Subject Matter Expert at Quell Therapeutics (London, UK) and were the Lead Scientist / Study Manager (Research Associate) of the Antigen Presentation Research Group at Imperial College London. Previously, at MSD Animal Health and Bristol Laboratories, I gained extensive experience in QC method transfer, stability studies, and lifecycle management of analytical assays. I have led the development and optimisation of a wide variety of methods, spanning label-free bioassays (biosensing), potency assays, ELISAs, PCR (quantitative and digital) and HPLC. My consultancy focuses on bridging science and regulatory expectations - from assay qualification and specification setting to analytical control strategy and data integrity. I bring a pragmatic, solution-driven approach to every project and ensure scientifically robust, inspection-ready deliverables. I collaborate with biotech startups, CROs and pharma companies worldwide to streamline analytical workflows and achieve compliance across the product lifecycle.

Subject Matter Expertise

• ★ Biochemical Assays
• ★ PCR
• ★ Bioanalytical Testing
• ☆ Natural Product Chemistry
• ☆ Physical Chemistry
• ☆ Biopolymers
• ☆ Polymer Chemistry
• ☆ Electrochemistry
• ☆ Biostatistics
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Oxidative Stress & Mitochondrial Function
• ☆ Antioxidants
• ☆ Binding Assays
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ Epigenetics
• ☆ Gene Expression Analysis
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Cytogenetics
• ☆ Gene Regulation
• ☆ Biotechnology & Bioengineering
• ☆ Microscopy
• ☆ Light Microscopy
• ☆ Fluorescence Microscopy
• ☆ Data Analysis
• ☆ Data Processing
• ☆ Data Exploration
• ☆ Data Visualization
• ☆ Data Collection
• ☆ Data Management
• ☆ Data Manipulation
• ☆ Text Mining & Analytics
• ☆ Biomarker Discovery
• ☆ Cell Culture
• ☆ Primary Cells
• ☆ Industrial Biotechnology
• ☆ Biosensors
• ☆ Population Genetics
• ☆ Cytometry
• ☆ Cell Aging
• ☆ Drug Development
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ Feasibility Studies
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Instructional Webinars
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Medical Writing
• ☆ Research Summaries & Abstracts
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ Release Notes
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ Spec Sheets
• ☆ Case Studies
• ☆ Science Communication
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing

Services

• Writing
• Research
• Consulting
• Product Development

Writing Medical Writing, Technical Writing

Research Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Stability/Shelf Life Testing, Product Evaluation, Quality Assurance & Control (QA/QC)

Work Experience

Scientist II, Analytical Development (R&D)

Quell Therapeutics Ltd

July 2023 - June 2025

Research Associate

Imperial College London

January 2022 - July 2023

QC specialist

MSD Animal Health UK

November 2020 - January 2022

Analytical Development Scientist

Bristol laboratories

October 2019 - November 2020

PhD candidate

Cardiff University

April 2016 - July 2020

National and Kapodistrian University of Athens

Research Associate / R&D Officer

May 2015 - March 2016

QC / AD / R&D Analyst

Greek Military Pharmaceutical Laboratories

November 2014 - August 2015

Education

PhD (Pharmacy and Pharmaceutical Sciences)

Cardiff University

April 2016 - July 2020

MSc (Pharmaceutical Technology)

National and Kapodistrian University of Athens

October 2012 - October 2014

BSc (Biochemistry and Biotechnology)

University of Thessaly

September 2008 - October 2012

Certifications

• n/a

  n/a

  January 2025 - January 2025

Publications

JOURNAL ARTICLE

Bostan, H.B., Taghdisi, S.M., Bowen, J.L., Demertzis, N., Rezaee, R., Panahi, Y., Tsatsakis, A.M., Karimi, G.(2018). Determination of microcystin-LR, employing aptasensors . Biosensors and Bioelectronics. 119. p. 110-118.

Katsarou, M.-S., Giakoumaki, M., Papadimitriou, A., Demertzis, N., Androutsopoulos, V., Drakoulis, N.(2018). Genetically driven antioxidant capacity in a Caucasian Southeastern European population . Mechanisms of Ageing and Development. 172. p. 1-5.

(2017). Effect of Olive Oil Phenolics on Lipidemic Profile and Oxidative Stress in Mice . Journal of Food Nutrition and Dietetics.

A Lymberopoulos and C Demopoulou and M Kyriazi and MS Katsarou and N Demertzis and S Hatziandoniou and H Maswadeh and G Papaioanou and C Demetzos and H Maibach and M Rallis(2017). Liposome percutaneous penetration in vivo . Toxicology Research and Application. 1. p. 239784731772319. {SAGE} Publications

Katsarou, M.-S., Karakonstantis, K., Demertzis, N., Vourakis, E., Skarpathioti, A., Nosyrev, A.E., Tsatsakis, A., Kalogridis, T., Drakoulis, N.(2017). Effect of single-nucleotide polymorphisms in ADH1B, ADH4, ADH1C, OPRM1, DRD2, BDNF, and ALDH2 genes on alcohol dependence in a Caucasian population . Pharmacology Research and Perspectives. 5. (4).

Katsarou, M.-S., Latsi, R., Papasavva, M., Demertzis, N., Kalogridis, T., Tsatsakis, A.M., Spandidos, D.A., Drakoulis, N.(2016). Population-based analysis of the frequency of HFE gene polymorphisms: Correlation with the susceptibility to develop hereditary hemochromatosis . Molecular Medicine Reports. 14. (1). p. 630-636.

Goutzourelas, N., Stagos, D., Demertzis, N., Mavridou, P., Karterolioti, H., Georgadakis, S., Kerasioti, E., Aligiannis, N., Skaltsounis, L., Statiri, A., et al.(2014). Effects of polyphenolic grape extract on the oxidative status of muscle and endothelial cells . Human and Experimental Toxicology. 33. (11). p. 1099-1112.