Γεωργία Κολεζάκη

Career focused on delivering excellence in client service in compliance with UK and USA regulatory requirements. Extensive experience in documentation preparation and regulatory compliance. Currently serving as Study Manager/Lead Scientist managing batch release and Cell Bank Characterization projects.

Strong expertise in regulatory inspections (MHRA/FDA), process improvement, validations, and mentoring teams. Demonstrates strong organizational skills, attention to detail, and ability to work effectively under pressure while managing multiple projects simultaneously.

Scientist of Analytical Services - Sartorius Stedim BioOutsource Ltd - Glasgow, Scotland

(2022-01)

Management of a variety of batch release and/or Cell Bank Characterization and testing projects. Working closely with the Sartorius Cell Bank manufacturing facility supporting delivery of manufacturing and testing projects to agreed timelines and quality standards.

• Responsible for overall conduct of studies ensuring compliance with appropriate GxP regulations
• Performance of Root Cause Analysis for deviations, Out of Specification and Out of Trend Investigations, CAPA implementations and continuous improvement projects
• Assay method validation, process troubleshooting, presenting and reporting results to Clients and stakeholders
• Production of client specific validation and qualification protocols and responsible for their execution
• Training personnel in a variety of Molecular assays and mentoring junior scientists
• Technology transfer of methods and SOPs from other departments within Sartorius and ensuring sustainability in laboratory operations
• Production of CSV documents, responsible for their execution and final technical assessment
• Subject Matter Expert in regulatory (MHRA/FDA) audits and client inspections
• Liaising with other teams to deliver excellent customer service

Associate Scientist - Sartorius Stedim BioOutsource Ltd - Glasgow, Scotland

(2019-11 - 2022-01)

Performance of a range of molecular assays to a high standard ensuring appropriate regulatory compliance. Assay methods included RT-PCR, qPCR, manual and automated nucleic acid extractions, Sanger sequencing, conventional PCR and gel electrophoresis, barcoding and Fingerprint DNA analysis.

• Supervision and training of other Associate Scientists
• Analysing and reporting data
• Managing of studies of limited complexity such as internal PCR reagent qualification studies

Graduate Biomedical Scientist - Laboratory of Haematology, General Hospital of Xanthi - Xanthi, Greece

(2016-12 - 2017-02)

• Cell staining and optical Microscopy for the investigation of sickle cell anaemia
• Review of scientific literature, responsible for data processing
• Maintaining accurate logs of work undertaken
• Contribution to study progress reports

Undergraduate Training - Laboratory of Immunology, Democritus University of Thrace - Thrace, Greece

(2015-06 - 2016-08)

• Mammalian Cell Cultures
• Performance and Interpretations of ELISAs
• RT-PCR and Cell-Based Assays

Cellular Biology Research Intern - Institute for Fishery Research - Kavala, Greece

(2014-07 - 2014-08)

• Lab housekeeping including ordering and maintaining stock levels
• Preparation of reagents and buffers
• Assisting with technical report writing

MSc - Brain Sciences - University of Glasgow (2017 - 2018)

BSc - Molecular Biology and Genetics - Democritus University of Thrace (2012 - 2016)