Iryna Zaiets Email & Phone Number

Sydney, Nsw, Australia

ACHIEVEMENTS• Successfully contributed to team projects involving manufacturing process development, significantly enhancing effectiveness in production operations.• Developed new techniques for sample preparation to enhance the characterization of nanoparticles, enabling more accurate and reliable analysis of product properties.• Conducted a series of successful experiments to refine the methodology of drug extraction.RESPONSIBILITIES• In-process and finished product analytical testing (including nanoparticles analysis by Nanosight, endotoxin assays, drug extraction, sterility testing and flow cytometry, etc.).• Perform analytical testing in PC2 laboratory, testing of GMO and cytotoxic products.• Maintain the QC laboratory processes, systems and documentation in accordance with GLP guidelines.• Perform and document routine calibration of laboratory instruments.• Develop and validate new and innovative analytical techniques for characterising nanoparticles therapeutics.• To participate in team projects involving manufacturing process development, pre-clinical and clinical research.• Follow all safety procedures and EnGeneIC’s Code of Conduct.• Any other duties as directed by the Managing Directors.

Kyiv, Ukraine

ACHIEVEMENTS• Gathered information and created a database encompassing approximately 40 projects, both new and ongoing, from inception, accelerating development processes.• Successfully brought an extemporaneous medication to market from concept to initial industrial batch within 3 months.• Developed a methodology for pre-project product assessment and accompanying documentation.• Developed proposals for optimizing Product Life Cycle (PLC) processes.• Formulated proposals for optimizing R&D business processes.• Established a temporary virtual Project Management Office to improve collaboration among project managers, enhancing company efficiency and effectiveness.RESPONSIBILITIES• Implementation of the Corporation's strategy and goals set by a Product Manager.• Planning, control and monitoring of the implementation of product portfolios project tasks .• Organisation of the pre-projects assessment process.• Assigning resources and development of project plans and budgets with project team members.• Monitoring of project milestones and goals and project risk management.• Analysis of project deviations and adjustments management.• Project status reporting to Head of Strategic Business Unit.• Product Life Cycle methodology optimisation (R&D and project pre-evaluation).• Analysis of the corporate structure and construction of the product life cycle process from idea to launch.• Organisation of a virtual PM-office and development of project management corporate culture.

Kyiv, Ukraine

ACHIEVEMENTS• Expanded product portfolio from 17 to 52 SKUs (from idea to launch).• Successfully registered 5 products in Europe.• Implemented modern online sales strategies.• Increased sales volume during economic crisis conditions.• Significantly modernized production site, resulting in increased productivity and improved product quality.RESPONSIBILITIES• Market research of cosmetic products, strategic analysis.• Product portfolio management.• Direct development of cosmetic products and scale-up.• Formulations and manufacturing processes optimisation.• Raw materials and packaging search.• Management of supply, stock of raw materials and finished products.• Design and purchase of the necessary production equipment, direct site equipment upgrade.• Production site management.• Quality control of intermediates and finished products.• Development of technical documentation for Registration of cosmetic products in Ukraine and EU.• Management of contract manufacturing of cosmetic products for customers from Ukraine and EU.• Labels and flyers design creation.• Creation of websites on the wix, uKit platforms and marketplaces.• Website content development and internet advertising.

Kyiv, Ukraine

ACHIEVEMENTS• Prepared 7 regulatory dossiers for submission in the EU and Asia.• Completed the registration dossier for Ukraine.• Developed 3 stable new formulations of solutions for injections.• Oversaw the production of 28 pilot-scale industrial batches.• Successfully completed 3 clinical trial batches.• Successfully developed and launched several new products for infusion therapy from concept to batch release on a new production site.RESPONSIBILITIES• Pharmaceutical R&D projects management.• Direct research and development of new medicines and scale-up.• Formulations and manufacturing processes optimisation.• Approbation of APIs, raw materials and packaging of alternative contractors.• Providing technology transfer on production site and producing series for clinical trials.• Planning of stability research and analysis of results.• Development of documentation in accordance with quality management system guidelines.• Development of technical documentation and Module 3 of Common Technical Document (CTD) for a dossier for the Regulatory Affairs and post-registration documentation.• Participation in review of nonconformities and complaints, audits and inspections.• Selection of the necessary laboratory and production equipment and instruments.• Screening candidates for R&D team and providing training.

Kyiv, Ukraine

ACHIEVEMENTS • Coordinated documentation development for product registration in the EU and Asia.• Successfully developed and launched 5 new products from concept to batch release.• Implemented technological improvements in the production process of multiple products.• Made significant contributions to a collaborative project aimed at modernizing production (ampoule filling lines).RESPONSIBILITIES• Direct research and development of new medicines and scale-up.• Formulations and manufacturing processes optimisation.• Approbation of APIs, raw materials and packaging of alternative contractors.• Providing technology transfer on production site and producing series for clinical trials.• Planning of stability research and analysis of results.• Development of documentation in accordance with quality management system guidelines.• Development of technical documentation and Module 3 of Common Technical Document (CTD) for a dossier for the regulatory affairs and post-registration.