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

Technical Consultant #2051

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.

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.

Credentials

Educator

Languages

Academic and Professional Affiliations

Publications

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