Pharmaceutical Bioprocess Validation and Compliance Consultant

Expertise

• Bioprocess engineering specific to equipment (equipment reliability and maintenance), systems and facilities.
• Bioprocess validation (aseptic processes, equipment, systems, facilities and cleaning).
• Technological process scale-up from bench top to pilot and commercial manufacturing.
• Biological active compounds and nanoparticle based drug delivery systems.
• cGMP manufacturing of pharmaceutical and biopharmaceutical products.
• Technology transfer to a Contract Manufacturing Organization (CMO) in Canada and U.S.A.
• Documentation review, disposition and release for cGMP manufacturing (batch records, SOPs, VP and WI).
• Single-use technologies development and implementation into biopharmaceutical manufacturing.

Experience

Undisclosed Company, Senior Consulting Engineer, Present

• Engineering support in the process validation; equipment and support systems qualification.
• Consulting services in the disposable technology application for manufacturing of HPAPI (High Potency Active Pharmaceutical Ingredient).
• Engineering support in contract manufacturing of complex liposome based drug delivery systems.
• Project lead for the new pilot scale manufacturing facility engineering, validation and start-up.
• Isolator technology development and application in cGMP manufacturing of drug products.

KDA Triglav Systems Ltd., Vancouver, Canada, BC, Senior Management Consultant, 2009 - 2012

• Engineering support in the process scale-up and technology transfer to CMOs.
• Project lead in collaboration with Tacmina Corporation to adapt Smoothflow technology for various biotechnological applications and pharmaceutical manufacturing.
• Support for regulatory submission through detailed process validation strategy engineering.
• Consulting services in the single use technology application in biotechnological processes.
• Consulting services to start-up companies to their support cGMP manufacturing of API and biologics.
• Engineering support in the process scale-up and technology transfer to CMOs.

Tekmira Pharmaceuticals Corporation, City of Burnaby, Canada, 1997 - 2008

Positions

• Group Leader, Technology Transfer, 2005 - 2008
• Senior Product Development Engineer, CMC, Manufacturing, 2002 - 2004
• Scientist III, Research and Development and Product Development, 1997 - 2001

Responsibilities

• Lead role in the development, engineering and the implementation of the scale-up strategy into company's manufacturing technology.
• Played a key role in the development and implementation of the process and the equipment validation strategy.
• Performed review and approval of QI/OQ/PQ protocols, WI and SOPs, VP and VR.
• Provided lead support in validation master plan engineering and post approval re-validation program development.
• Successfully validated cleaning procedures for liposome based formulations and siRNA manufacturing processes.
• Planned and executed manufacturing operation on site and at CMO for anticancer and immunostimulatory liposomal injectable drug products.
• Provided daily support and trouble-shooting with all cGMP related manufacturing activities (facilities preparation, equipment maintenance, line clearance).
• Acted as engineering lead (project manager) in the single use technology application to the aseptic manufacturing of liposome based products on the pilot plant scale.
• Planning and coordinating the quality assurance activities of vendors, stakeholders and contract resources.
• Assisted QA department with resolution of quality issues as person in plant representing PD/manufacturing department at a contract manufacturer sites.
• As a key representative of the manufacturing department, participated in batch record issuance, compilation, review and disposition.
• Actively participated in development of the manufacturing systems such as non-conformances, FMEA and CAPA, implementation of change control and QbD programs.
• Led Statistical Process Control, (SPC) analysis in the determination of preventive actions required on the side of CAPA development.
• Performed batch record review and resolution of deviations with various CMO.
• Participated in the development of training records for manufacturing personnel of various CMO during technology transfer activities.
• Performed GLP & GMP audits of laboratories and commercial manufacturing units.
• Hosting FDA regulatory inspections in cGMP manufacturing facilities and PD laboratories.
• Participated in cGMP facilities inspection prior to manufacturing campaign and ensuring environmental control.

Honors & Publications

Credentials

• Professional Engineer-P.Eng., BC, Canada
• IT proficient (Wrike, Word, Excel, PowerPoint, Outlook, Databases, Calibration Manager).

Languages

• Russian, mother tongue.
• Czech, conversational, and reading.

Patents

• WO patent: Production improvement of lipid vesicles.

Education

• M.S. Process Engineering, State University, Chemical Technology, Moscow, Russian Federation
• B.S. Process Engineering, State University, Chemical Technology, Moscow, Russian, Federation