• Oversaw operational activities, ensuring alignment across departments, production sites, and resource optimization to enhance efficiency and minimize costs.• Developed and implemented corporate strategies, risk assessments, and portfolio management initiatives in Life Sciences to drive market growth.• Conducting strategic and commercial evaluations of new products, technologies and process automation to improve quality and cost efficiency.• Led chemical and process development across the value chain, from drug discovery to clinical supplies and commercial registration of new chemical entities.• Directed development plans for APIs, drug products, devices, packaging, and launch preparations, ensuring regulatory approvals within strict timelines and budgets.• Established clinical collaborations with international CROs, academic institutions, and industry leaders to leverage global expertise in various therapeutic areas.• Managed deal structuring, negotiations, and partnerships with CMO/CDMO, CRO companies, and governmental organizations to secure contracts and finalize agreements.• Promoted company products and secured new investors through targeted business development initiatives, including organizing negotiations and meetings, and finalizing contracts for the sale of products and procurement of necessary materials.• Developed analytical tools and market access frameworks to support decision-making in the pharmaceutical and distribution sectors.• Engaged with federal and local regulatory authorities to ensure compliance and project execution.• Coordinated cross-functional collaborations with discovery, development, QA, clinical, and business development teams to advance key projects.• Fostered partnerships with academic and research centers to drive innovation and scientific cooperation.

• Managed national and international customer projects within the medical and pharmaceutical industries, combining strategic planning, market analysis, relationship building, and sales to achieve business goals.• Developed and expanded customer relationships, identifying new opportunities and maintaining strong ties with existing clients.• Led the introduction, maintenance, and advancement of quality management systems, including ISO 13485, ISO 9001, MDSAP, GMP, GLP, GDP, and others, ensuring compliance with industry standards.• Implemented integrated and decentralized management systems, tailored to the specific needs of organizations, improving overall operational efficiency.• Developed and maintained regulatory affairs systems in compliance with global standards, including MDSAP, FDA, ANVISA, CFDA, JPAL, and TGA.• Conducted GAP and DELTA audits, identifying areas for improvement and ensuring full regulatory compliance.• Provided audit support for clients during regulatory evaluations by authorities, notified bodies, and certification bodies.• Held leadership and interim business development (BD) and operational roles at angel and VC-backed MedTech and Pharma companies.• Managed customer and R&D projects, ensuring timely delivery, cost efficiency, and alignment with market trends and regulatory changes.• Represented the company externally, making initial contact at conferences, associations, and other industry events, and managing client relationships from project evaluation through contract negotiation and post-deal management.• Built strong relationships with international manufacturers, providing technical guidance on process scale-up, analytical assay development, documentation, capacity building, and licensure.• Supported clients through manufacturing optimization, continuous improvement projects, regulatory support, and quality systems implementation.

• Directed business development activities, driving growth through new client acquisition, ongoing client support, and project success.• Planned and executed project strategies across all stages, from conceptualization to final implementation, ensuring alignment with business objectives.• Identified and managed licensing, development, and manufacturing partnerships (CMO/CDMO) to enhance the company pipeline and support growth.• Oversaw project portfolios across company divisions, aligning business needs with client interests and optimizing resource use.• Collaborated with Marketing, R&D, and department heads to establish clear stage-gate criteria for portfolio products, ensuring effective decision-making and customer satisfaction.• Provided strategic guidance and expertise in product development, innovation, and project management to support business expansion.• Managed budgets for subordinate divisions, ensuring efficient allocation of resources and cost control.• Led the development and launch of new product brands, overseeing their market introduction and performance.• Spearheaded the design, implementation, and expansion of a custom cGMP facility, enhancing production capabilities and ensuring compliance with industry standards.• Negotiated agreements and managed relationships with external manufacturing and development partners.

• Defined and implemented CMC (Chemistry, Manufacturing, and Controls) strategies to support product development, clinical programs, and regulatory submissions.• Managed CMC timelines, budgets, and information flow, ensuring alignment with internal teams, partners, and stakeholders across production, quality, and R&D.• Led technology transfer projects, overseeing scale-up, manufacturing plans, and collaborations with CMOs/CDMOs for drug substance (DS) and drug product (DP) production.• Authored and reviewed CMC sections of clinical regulatory submissions (INDs) and coordinated responses to US (FDA) and European (EMA) regulatory authorities.• Provided CMC technical leadership for drug substance, drug product, analytical development, clinical manufacturing, and supply chain activities.• Spearheaded technical due diligence to identify and establish strategic partnerships with CMOs, CROs, and contract test labs for manufacturing and analytics.• Prepared key reports, strategic concepts, and analytical materials to support executive decision-making and project implementation.• Represented the company as a CMC expert before regulatory authorities, ensuring compliance and project advancement.• Collaborated with cross-functional teams (R&D, Quality, Product Development) to deliver clinical programs, expand business operations, and integrate new technologies.• Appointed as Head of CMC/CTO for a seed-stage startup focused on COVID-19 vaccine development, successfully establishing manufacturing plans and clinical execution.• Oversaw proprietary production processes and guided projects from R&D to commercialization, fostering long-term strategic partnerships.

• Led the optimization of production processes, enhancing efficiency across three manufacturing sites while ensuring compliance with GMP quality standards and regulatory requirements.• Managed production operations across solid dosage forms, biotech products, and API/vaccine manufacturing, overseeing all stages, from technology transfer to production scheduling and logistics optimization.• Coordinated cross-functional activities (finance, engineering, quality control, regulatory) to align with company goals and manage partner negotiations.• Presented production activities to company management, Russian and international partners, ensuring alignment with business objectives.• Oversaw project implementation, including budgeting, monitoring, and compliance with strategic goals.• Managed operating expenses and increased liquidity, driving financial performance and P&L responsibility.• Fostered strong relationships with existing and potential partners, suppliers, and customers to support business growth.• Led the creation and management of diverse teams, promoting talent development and cultivating a strong company culture.• Directed the implementation of cGMP standards across development, manufacturing, quality assurance, compliance, and supply chain operations for key clients such as Merck and Sanofi.• Managed complex CMC development projects, leading international teams through analytical, synthesis, formulation, and industrialization phases, ensuring regulatory compliance and operational efficiency.• Led the tech and analytical transfer of five biosimilar products, achieving EMA and EAEC approval while aligning technical operations with regulatory requirements and strategic timelines.• Planned and coordinated the creation of new production facilities and capacities to meet growing business needs.• Prepared for and managed scheduled and unscheduled regulatory inspections, ensuring full compliance with GMP and other relevant regulations.

• Managed and developed the R&D department, leading multifunctional project teams to drive organizational improvements and enhance team competencies.• Fostered cooperation and communication within internal divisions and with external partners, contributing to strategic, innovative projects and product concepts.• Led employee training and professional development initiatives across the company.• Promoted and implemented global strategic decisions locally, ensuring alignment with organizational goals.• Improved API production processes and created a pipeline of innovations for future growth.• Oversaw budget management, including planning, monitoring, controlling, and approving operating costs.• Developed and maintained relationships with institutional partners and regulatory authorities, overseeing the local regulatory department.• Defined technology roadmaps and product solutions aligned with strategic timelines.• Managed projects focused on maintaining high quality standards and cost-effectiveness.• Held strategic and operational responsibility for the development of new products and the enhancement of existing solutions.• Collaborated with scientific organizations and universities to foster R&D partnerships.• Managed clinical research at the country level in accordance with Good Clinical Practice (GCP) and local regulations, ensuring scientific integrity and quality.• Directed end-to-end planning, budgeting, facility design, process scale-up, and equipment procurement for new manufacturing facilities specializing in antibiotics, creams, and capsules.• Successfully delivered multiple R&D projects on time, within budget, and to high-quality standards, contributing to profit growth.• Managed investment projects and negotiated with CROs and CMOs for drug substance and product manufacturing in GMP and non-GMP environments.

• Led and optimized engineering processes, driving operational excellence and the successful development of key projects across multiple teams.• Directed and coordinated laboratory and departmental activities, overseeing project management, planning, and cross-functional team collaboration.• Led and mentored R&D and pilot plant teams, ensuring effective management of production processes, route selection, and life cycle management.• Championed the scaling-up of R&D equipment to industrial scale, ensuring successful process characterization, validation, and equipment maintenance.• Guided the seamless transition of projects from R&D to manufacturing, managing technology and analytical transfers while maintaining focus on quality and timeline.• Coordinated and aligned internal and external CMC plans for biopharmaceutical and clinical studies, fostering collaboration across teams.• Led the scouting, screening, evaluation, and negotiation of licensing-in or acquisition opportunities, ensuring alignment with long-term business strategies.• Oversaw technical and commercial relationships with strategic contract manufacturers, leading the selection, negotiation, and auditing processes to strengthen partnerships.• Led chemical and process development for APIs (Small Molecules, Oligonucleotides & Oligopeptides) from R&D through clinical Phase III to commercial production, ensuring regulatory compliance and operational success.• Led DS and DP technology transfer, scale-up, validation, and commercial launch production, ensuring project success and timely delivery.• Demonstrated expertise in Quality by Design (QbD), Process Performance Qualification (PPQ), and launch readiness, ensuring adherence to industry standards.• Led the design, planning, budgeting, construction, qualification, and successful EMA inspection of a state-of-the-art Pilot Plant, enhancing production capabilities and ensuring regulatory compliance.

• Participated in the ENCAP project, funded by the European Commission (EC) and Industrial Partners in Automotive and Gas production Industrie.• Led a multicultural team, including PhD and Master's students.• Responsibility for frequent communication and reporting to EC and partners including research status and funding. • Developed advanced gas purification and production systems, using membranes, plug-flow, and semi-batch catalytic processes.• Compilation and analysis of qualitative data on process used and writing of research protocols; • Achieved cost-effective production solutions through the integration of new technologies and reorganization of the manufacturing process.• Lectures and student’s supervision, including overseeing doctoral theses.

• Managed supply chain teams, quality control laboratories, and production processes, ensuring efficient raw material flow, robust manufacturing, and product life cycle execution.• Developed and implemented procurement strategies to optimize costs and enhance supply chain efficiency, including supplier performance evaluation, issue resolution, and long-term partnership management.• Troubleshot, optimized, and scaled up technologies, introducing new production lines, equipment, and innovative manufacturing solutions to meet current and future business needs.• Established and led an in-house development laboratory, including staff recruitment, lab setup, and instrumentation procurement.• Ensured compliance with quality systems and regulatory requirements, serving as a liaison for regulatory inspections, Pre-Licensing Inspections (PLI), and periodic audits.• Conducted internal and external audits, including supplier qualification, evaluation, monitoring, and development of quality agreements.• Coordinated Quality Management Reviews, prepared and maintained quality-relevant documents (e.g., SOPs), and ensured site-wide adherence to quality systems.• Provided technical support for inspections, regulatory inquiries, and customer-related product quality matters.• Organized internal training sessions focused on quality systems and process improvement to enhance operational efficiency.• Supported technology transfer projects, scaling up new devices and processes while optimizing existing technologies for enhanced performance.• Acted as the quality and regulatory interface for customers, suppliers, authorities, and employees, ensuring smooth communication and compliance.• Created and maintained comprehensive documentation and reports to support quality and operational functions.• Led business development activities for new and existing clients, including entrepreneurial setup of new business initiatives.

Ph.D. study: Controlling Porosity and pore size distribution in green ceramicbodies via Freeze-casting method