Еugenia Ilina Email & Phone Number

Toronto, ON, CA

Cambridge, Ontario, Canada

• Led the group of 3 formulators, ensuring they operate safely, smoothly and efficiently, in accordance with GMP and GLP requirements. Responsible for effective R&D plan execution within the given time frame
• Collaborated with cross-functional teams to ensure project milestones were met, including Manufacturing, Quality Control and Quality Assurance
• Actively maintained Quality Management Systems, including developing standard operating procedures and training team on quality procedures
• Searched and developed new ideas and breakthrough technologies to achieve the goal

• Acting as a scientific leader, ensuring the efficient pharmaceutical development of liquid drug products and medical devices, including literature search, raw material, primary packaging and accessories evaluation.
• Participated in technology transfer, validation, stability studying and results assessment
• Mentored new team members.

• Performed the development and enhancement of pharmaceutical formulations and manufacturing processes in accordance with Pharmacopeias, ICH and GMP requirements, including design of experiments, result evaluation, and.
• Searched raw materials, and selected primary packaging within the specific characteristics of each product. Liaised with suppliers to obtain up-to-date information about new market developments
• Conducted lab-scale studies, using glassware and specialized lab equipment and instruments, including scales, pH-meter, Osmometer, Moisture analyzer, Optical microscope, Viscometer, Rheometer, Laser Diffraction.
• Performed pilot scale batches preparation in clean rooms environment, following SOPs and GMP requirements, leveraging various process equipment, including Scales, Mixing vessels with diverse mixing tools, Pumps, Dosing.
• Performed records to ensure traceability, prepared reports and protocols
• Developed CTD dossier (Module 3), and responded to Regulatory Affairs queries.

Ukraine

• Maintained Quality Management System
• Coordinated change control activities, participated in deviation investigations, risk identification and assessment and CAPA procedures
• Oversaw the development of Quality System documents including policy, SOPs, instructions, guidance and forms and templates in collaboration with related departments
• Reviewed and updated the Site Master File.

Responsible for formulation and manufacturing processes development for sterile liquid dosage forms in accordance with GMP, ICH and Pharmacopoeias requirements

• Conducted stability testing, using organoleptic, visual, pH-, viscometry, wet chemistry, spectrophotometry-, and thin layer chromatography methods in accordance with written procedures and GMP/GLP requirements
• Collected and analyzed stability data, developed documents and reports
• Operated and maintained laboratory analytical equipment and climate chambers
• Performed equipment calibration