Goksu Tokac Email & Phone Number

Germany

Bergisch Gladbach, North Rhine-Westphalia, Germany

• Conducting GMP-compliant quality control tests for cell-based medicinal products, including flow cytometry, microbiological tests, and endotoxin tests.• Detailed documentation of tests in compliance with GMP & GDP standards.• Planning and optimizing processes within the laboratory.• Performing qualification and calibration of laboratory equipment as equipment responsibel.• Validating GMP-compliant analytical procedures.• Preparing and maintaining essential GMP documents such as SOPs, IOPQ Plans, change controls.

Izmir, Turkey

• Successfully completed an R&D project supported by the Scientific and Technological Research Council of Turkey (TUBITAK), securing funding in a highly competitive selection process (acceptance rate of 38.5%).• Managed all aspects of the project, including task coordination between divisions, report writing, and defense presentations.• Established a microbiology laboratory within the factory, ensuring compliance with 17025 standards.• Upgraded the chemistry laboratory, enhancing its capabilities and efficiency.• Managed a team of four, organizing workflow and ensuring optimal performance.• Conducted suspension testing to evaluate antibacterial/antifungal/sporicidal efficacy of disinfectants.• Performed chemical analyses of chlorine, water, brine, and salt for quality control purposes.• Managed and successfully completed the "Biocidal Product Licensing" process of the relevant disinfectant.• Managed funded projects, providing guidance on scientific methodologies aligned with research strategies.

İzmir, Turkey

Izmir, Turkey

During my work period at the Trio Grup CRO, I coordinated a multicentered phase III nephrology project and a single centered oncology project.In order to manage these projects and sites successfully, I followed GCP guidelines. A day's work included but was not limited to the following tasks:• Managing investigation files,• Communicating with site staff, study subjects and study CRAs,• Obtaining necessary documents, signatures and lab reports for the study,• Confirming timely delivery and destruction, as well as the adequacy of clinical drugs,• Recording of Serious Adverse Events in time,• Organizing Investigator Files and helping with Case Report entries,• Organization of sample shipments to laboratories,

Izmir, Turkey

• Developed proficiency in GMP and expanded skills in microbiology techniques.• Conducted identification analysis of pathogens, GMOs, soy, and meat species using molecular techniques (DNA isolation, DNA quantification, PCR).• Utilized basic microbiology methods such as pour plate, streak plate, and biochemical confirmation analysis.• Evaluated and reported results according to ISO 17025 standards.• Managed two subordinates, resolving quality problems effectively.• Ensured process control and environmental quality monitoring (microbiological) throughout the factory, aligned with ISO 22000 Food Safety Management System.• Prepared for and participated in local and international external audits.

The Hague Area, Netherlands

• Conducted a research project with the R&D team under the Human Biological Traces Department, led by Dr. Titia Sijen.• Specialized in molecular methods, including all aspects of DNA and RNA profiling.• Implemented aseptic techniques and quality protocols to maintain sample integrity.• Achieved a performance rating of 8 out of 10.• Published thesis results in a peer-reviewed journal.

Master Of Science (M.Sc.)

Bachelor Of Science (B.Sc.)