Bioengineer CMC Expert Specializing in Parental Drugs, Recombinant Protein and Vaccines

Technical Consultant #2051


Expertise

  • 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.

Specialized Technologies

  • 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.

Experience

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

Credentials

Educator

  • 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

Languages

  • 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.

Publications

  • Author: Several publications for conferences and forums

Education

  • M.S. Bioengineering, Mendeleyev Institute of Chemical Technology, Moscow, Russia, (Department of Microbiology and Biotechnology)
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