- Pharmaceutical drug development, regulatory affairs, and commercial manufacturing of biologics and combination products.
- Recombinant proteins of different classes, vaccines, plasmids, small molecules, and combination products involving controlled release formulations.
- Preform scale up of downstream processes.
- Development and optimization of protein purification in the recombinant protein production.
- Regulatory requirements for biopharmaceutical development and manufacturing of drug substances and drug products, both sterile and non-sterile.
- CMC (Chemistry Manufacturing and Controls) sections for IND (Investigational New Drug) and IMPD (Investigational Medicinal Product Dossier) submissions that received fluent regulatory acceptance.
- Development of pharmaceutical products in different production systems including bacteriological, mammalian, and plant systems.
- Regulatory submissions and interactions with the regulatory agencies both domestic and foreign.
- Contributed to the advancement of numerous drug leads and marketed pharmaceuticals at BiogenIdec, Xanthon, Diosynth (Fujifilm), Biolex and Synthon.
- Parental products.
- Recombinant protein and vaccine production, purification, characterization and analysis.
- Production systems: plants, bacteriological, insect and mammalian cultures.
- Plasmid, viral particles (VP), protein purification.
- Final formulation development and optimization.
- Wide variety of analytical and bioassay techniques.
- Molecular biology and genetic methods.
Undisclosed Company, Senior Consultant, 2007 - Present
- Regulatory support and preparation of regulatory documents (IND, CTD, ANDA, BLA)
- Regulatory support and strategy development.
- Quality system implementation.
- Validation (processes, equipment, cleaning, analytical).
- GxP and due diligence audits/PAI mock audits.
- Optimization for successful pharmaceutical development for the products including pre-clinical, clinical, commercial: DNA-RNA-vaccines, recombinant proteins, plasmids, small molecules, combination products, and medical devices.
- Technology development, scaling up, and optimization.
Synthon Pharmaceuticals Inc. RTP, ,NC, Sr. Director QA and CMC, 2012 - 2013
- Qualification of contract manufacturing organizations for API, sterile products, packaging, labeling, distribution. Biopharmaceuticals.
- Managing CMC in compliance with the regulatory guidance and guiding the company's submission team on CMC regulatory path forward for clinical candidates and commercial products, both biologics and generics.
- Regulatory authoring and managing CMC documentation.
- Quality assurance oversight of the U.S. operations and managing product release by Synthon affiliated sites for U.S. distribution
- Providing CMC and QA support and guidance to the engineering teams on facility design, construction, and validation.
- Establishing and driving quality improvement functions within the international Synthon QA units (U.S., Spain, and the Netherlands).
- Implementing policies and practices for Quality by Design (QbD) and risk management in product development, manufacturing and life-cycle.
- Providing company wide support and guidance for manufacturing and validation of parenteral products.
Biolex Therapeutics, Inc., NC, Sr. Director QA, 2003 - 2012
- Company Executive Committee Member and Intermediate positions held within the company: QC Director, QA and Regulatory Director.
- CMC strategy development for clinical candidates at phase 1, 2, and 3 development.
- Managing and writing CMC regulatory documentation for US and foreign applications for clinical candidates at different stages of development.
- Managing and developing annual reports and comparability strategies for investigational medicinal products.
- Participating at Type B and Type C meetings with the FDA and scientific meetings with EMA Innovation Task Force.
- Leading multi disciplinary Phase 3 readiness program driven by the departmental heads from engineering, manufacturing, validation, IT, quality control, and technical support.
- Due diligence, contract development and management of the contract manufacturing sites.
- Qualification of contract manufacturing companies.
- QA oversight of the technology transfer and process validation for both drug substances and sterile drug products.
- Implementation of GxP systems and managing QA and QC groups.
- Managing clinical quality assurance functions.
- Leading cross-functional Quality Management Review and Improvement Committee.
Diosynth, Inc., Research, (Fujifilm), NC, Manager, Quality Assurance, 2002 - 2003
- Managing product manufacturing and release for two pharmaceutical companies at Phase 2 and Phase 3 clinical development.
- Managing validation activities for analytical testing, processes, facilities, computer systems, and cleaning processes.
- CMC strategy development for regulatory submissions.
- Quality management review.
- Implementation of risk management practices.
- Developing program for supplier qualification.
- Internal, external and supplier audits.
Xanthon, Inc. Research, NC, Quality System Manager, 2000 - 2002
- Establishing and managing the quality system department.
- Implementation of design control and quality system procedures compliant with FDA regulations.
- Development and implementation of standards, methods and procedures for inspection, testing and evaluation of the precision, accuracy and reliability of company products (device).
- Implementation and management of instrument/equipment validation (IQ, OQ, PQ), calibration and maintenance programs in manufacturing and QC departments.
- Managing Material Review Board (MRB) and Quality Management Review (QMR) committees.
- Writing and approval of manufacturing procedures, Device Master Record (DMR), device history records (DHR), and packaging specifications.
- Providing technical and managerial leadership for validation activities.
Biogen, Inc, Research, NC, Quality Analyst III, 1996 - 2000
- Significant role during commercial facility approval for Avonex manufacturing.
- Key role in the technology transfer from site to site and validation.
- Responsible for analytical method development, transfer, validation and optimization.
- Assisted in the preparation of CMC sections for BLA submission.
- Supervised company - wide software validation program, 21 CFR Part 11.
Russian Academy of Science, Shemyakin Inst., Bioorganic Chemistry, Moscow Russia, 1989 - 1995
- Leading Chemical Engineer for the Department of Biotechnology.
- Set up and oversaw a new laboratory for Plant Cell Culture.
- Managed four grants.
- Responsible for the development and optimization of protein purification in the recombinant protein production.
- Performed scale-up of the downstream processes.
Honors & Publications
- Qualified Person Forum, Biolex
- Creative Leadership Development course for senior management, Biolex
- Kepner Tregoe Problem Solving Course, Diosynth
- Quality Engineering Course, Xanthon
- Quality Management in a QC laboratory, Biogen
- Part 11 CFR 21 Course, Biogen
- Statistics (SAS, NWA,), Biogen
- Russian: First Language
- English: Fluent
Academic and Professional Affiliations
- Parenteral Drug Association - PDA
- International Society for Pharmaceutical Engineering - ISPE
- Drug Information Association - DIA
- Qualified Person - European Union Pharmaceutical Regulation
- Grant management.
- Author: Several publications for conferences and forums
- M.S. Bioengineering, Mendeleyev Institute of Chemical Technology, Moscow, Russia, (Department of Microbiology and Biotechnology)