Dionys Muratov

Analytical and detail-oriented pharmaceutical R&D and quality professional with more than 13 years of experience in analytical method development, quality assurance, regulatory documentation, pharmaceutical research, and cross-functional project coordination. Proven experience building and leading a multidisciplinary analytical R&D department, directing analytical support for more than 300 product-development projects, and personally managing selected pharmaceutical development and registration projects. Adept at analytical method development and validation, technology transfer, CTD Module 3 preparation, GMP-regulated operations, and collaboration with quality control, production, regulatory affairs, and technical teams.

Co-inventor on three pharmaceutical patents and co-author of a peer-reviewed scientific publication.

Head of the Analytical Methods Development Department at Grotex LLC (Solopharm) (2014-01 – 2024-12)

Built and led a multidisciplinary analytical R&D department supporting pharmaceutical and medical device development, registration, technology transfer, and commercial manufacturing.

• Expanded an initial team of two chemists into an independent multidisciplinary department with more than 25 employees.
• Designed the organizational structure and established specialized teams for analytical method development, pilot-batch support, method validation and transfer, and stability studies.
• Recruited, trained, and developed employees; coordinated sector managers and their teams; assigned responsibilities; reviewed analytical work; and approved departmental documentation.
• Planned laboratory equipment, consumables, analytical capacity, storage requirements, and laboratory space in coordination with quality control, production, engineering, and other internal functions.
• Directed the department's analytical support for more than 300 projects involving pharmaceuticals, medical devices, and dietary supplements.
• Coordinated analytical method development, validation, implementation, stability testing, registration support, technology transfer, and transfer to commercial manufacturing.
• Personally managed selected development and registration projects, including ophthalmic products containing latanoprost, tafluprost, and travoprost, as well as low-molecular-weight heparin products containing enoxaparin and dalteparin.
• Served as development lead and principal R&D contributor on projects resulting in three pharmaceutical patents on which I am named as a co-inventor.
• Coordinated the preparation of CTD Module 3 documentation for selected projects and international registrations, including pharmaceutical development, manufacturing processes, material and product controls, analytical methods, validation, specifications, packaging, and stability data.
• Adapted Module 3 content to national requirements and collaborated with external regulatory consultants on local requirements, translations, and communications with foreign regulatory authorities.
• Supervised analytical method validation and transfer to quality control laboratories and manufacturing sites and supported deviation investigations and continuous improvement activities.
• Contributed to annual departmental budget planning, monitored approved expenditures, reported variances, and planned costs for equipment, maintenance, repairs, consumables, and laboratory modernization.

R&D Scientist at Niko LLC (Nikopharm) (2010-01 – 2014-12)

Contributed to pharmaceutical development and registration through formulation and manufacturing technology development, implementation of GMP-aligned scientific and technical procedures, and cross-functional collaboration.

• Developed and implemented an optimized manufacturing technology for a generic injectable product containing tolperisone and lidocaine, simplifying raw-material sourcing, inventory control, and related production-support processes.
• Implemented policies, standards, and procedures for scientific and technical work in accordance with GMP requirements.
• Collaborated with quality control, marketing, and regulatory affairs teams during pharmaceutical development and registration activities.

Master's Degree in Chemistry – Donetsk National University (2005-01)