Director, External Manufacturing Business Operations

Achievements:

 Successfully transition of Organon Product Portfolio manufactured at External Partner’s sites within spin-off of Organon from MSD.
 Development of local representative External Manufacturing Operation of Organon company formed through spinoff from Merck & Sharp & Dohme (MSD).
 Strategic partnership development for several External Partners in Russia & CIS.
 Focus Factory Team management by achieving excellence in Compliance, Supply, Continuous Improvement & Cost Reduction in partnership with respective functional teams.

Key responsibilities:

 Primary owner of Strategic Alliance Ext. Manufacturing relationship with the External Partners (ExP) and main point of contact for all dealings between Parties.
 Support Regional and Global Leaderships in developing and executing External Manufacturing Network Strategy.
 Responsible for ensuring contract terms agreed, incl. Purchase Orders, Forecasts, Deliveries and Invoice Payments are executed in compliance with the Manufacturing & Supply Agreement.
 Drive relationships with key suppliers: develop and lead regular performance reviews (S&OP, CIP execution, QBR, Planning, Quality reviews, etc.), lead all aspects of product tech transfers, engage suppliers in lean process improvements and manage operations via plant management.
 Responsible for all operational related activities and is primary point of contact for:
o Dispute resolution (with appropriate escalation);
o Materials Management (ERP transactions, Logistics);
o Quality issues (Deviation Management, Product Release, Change Control);
o Technology issues;
o Oversight of shop floor production;
o Continuous Improvement activities.
 Responsible for proactively drive risk assessment across the whole value chain and work closely together with Focus Factory team to manage and mitigate risks to aim at zero interruption of the supply chain and to ensure 100% compliance in Quality and in Environment, Health and Safety.
 Develop Ops Plans (incl. budgets, volume planning, etc.) with EM sites; ensure alignment on the outcomes with key internal partners.
 Identify potential Quality/Regulatory, Technical and/or Supply Chain challenges and work with key internal stakeholders and EM sites to resolve.
 Facilitates the collection of ExP capacity information (e.g., stated capacity, future capacity plans, lead times required, comments/concerns, etc.) in preparation for future Assumption Based Reviews (ABRs).
 Facilitates Supply Chain (i.e., design, plan, source, make and deliver), knowledge of cross-functional interdependencies and an understanding of the interactions with internal sites to achieve operational excellence.
 Responsible for operational processes to develop and execute programs and initiatives to drive for mutually beneficial business results.

Achievements:

 Technical Transition of Organon Product Portfolio manufactured at ExPs sites through spinoff of Organon company from MSD.
 Manufacturing & Supply Agreement signing with key ExPs for contract manufacturing and licensee deals to continue the business of Organon Product Portfolio in Russia & CIS.


Key responsibilities:

 Lead and act as the primary interface on technical issues between Technical Operations and ExP.
 Responsible for the management of the technical interface between Organon and ExPs in Russia &CIS.
 Facilitates the collection of ExP capacity information (e.g., stated capacity, future capacity plans, lead times required, comments/concerns, etc.) in preparation for future Assumption Based Reviews (ABRs) for Organon Product Portfolio in the future.
 Facilitates Supply Chain (i.e., design, plan, source, make and deliver) of future Organon Product Portfolio, knowledge of cross-functional interdependencies and an understanding of the interactions with internal sites to achieve operational excellence.
 Responsible for operational processes to develop and execute programs and initiatives to drive for mutually beneficial business results for Organon Product Portfolio in the future.

Achievements:

 Establish and development of the new department in Russia, responsible for the pharmaceuticals & biotechnology products localization.
 Strategic partnership establishment for several CMOs.
 Transfer of contrast media complicated technology and launch of local products due to the generics launch on the Russian market in 2019. As a result, company saved of diagnostic products sales in Russia.
 7 completed technology transfer projects to several CMOs in Russia (parenteral & solid dosage formulations) within the Pharma-2020 program.
 4 completed projects of existing production facilities expansion within commercial operations (parenteral & solid dosage formulations).

Key responsibilities:

 Bayer representative and operations interface to the external contract manufacturing partners.
 Lead the cross-functional Bayer/CMO team and drives the daily operations at the contract manufacturers in support of robust market supply of locally marketed products.
 Provide leadership and mentoring, resource planning within the department.
 Management and technical supervision of contract manufacturing within Bayer localization program in Russia.
 Lead the Bayer/CMO cross functional operations team (regulation, quality, procurement, logistics, etc.) and supervise and direct the external partners in daily operation in terms of change management, deviation management, issue and risk management and KPIs.
 Manage, monitor and record the performance of all aspects of the CMO and ensure all KPI’s are met. Perform the monthly business reviews and actively drive continuously improvement of routine operations towards agreed goals.
 Represent EM in global projects and manage in technology transfers the operational and GMP relevant elements for the production/packaging process and analytical methods.
 For products at assigned CMOs ensure adherence and up to date Change management documentation. Ensure timely, accurate and cGMP conform documentation of production and that standards and requirements of Bayer, cGMP, Health Authorities are met.
 Review and align the production schedules for assigned CMOs with internal stakeholders and ensure established inventory levels are met while operating at high economic efficiency.

Novo Nordisk Engineering (NNE) Phamaplan, Project mangement Dept.
Sr. Project manager (2010-2013)

Achievements:

 Conceptual, basic design and startup of the new Novo Nordisk plant to produce of insulin drugs in Russia (Greenfield project).
 Audit of aseptic production for compliance with cGMP EU requirements (the customer is a well-known Russian pharmaceutical company).
 Audit and conceptual design of solid dosage forms with high-potential isolators technology (customer - a well-known Russian pharmaceutical company)
 Conceptual design of aseptic production site (customer - leading manufacturer, Russia)
 Concept design, basic design of solid dosage forms with high-potential technology (isolators), incl. direction of QC-Laboratory, development of URS (customer - a leading international manufacturer of biopharmaceuticals, England / Sweden).
 Conceptual design, basic design of the existing production of infusion solutions, capacity increase (customer - head pharmaceutical company, Germany).

Key responsibilities:

• Project management, project strategy, project execution plans, time management, planning tasks and allocating resources, working in teams, quality management, monitoring and reporting, documentation and record keeping.
• Supervision, leadership and management processes/procedures involving the acquisition of supplies and services; acquisition planning to include performance-based considerations;
• Cost and price analysis; solicitation and selection of sources;
• Contract negotiation and award of contracts; all phases of contract administration; termination options and processes for closeout of contracts; legislation, policies, regulations, and methods used in contracting, and business and industry practices, with particular emphasis on: participation in determination of contract approach
• Preparation of technical design specifications
• Management of contractor performance and contract administration. Communication/negotiate with suppliers and subcontractors. Control over for technical tasks for subcontractors.

Lead process engineer (2008-2010)
• Conceptual, basic, detail design, strategic planning with focusing to biotechnological and pharmaceutical manufactures, the analysis of processes and management as the head of technological group.
• Develop the design scope specification for major projects, ensuring appropriate input and sign-off.
• Support the quality and technical team by mentoring less experienced members.
• Works in cross functional teams to improve plant efficiencies and reduce costs.
• Plan and coordinate projects from initial concept through to approval of funds and eventual operational installations.
• Conducts engineering assignments with the knowledge that changes in one area may have flow-on effects in other areas of the process.
• Uses the management of change and process hazards analysis procedures to ensure the safe implementation of plant / process changes.
• Contribute to adherence to safe work practices, high quality workmanship, and a proactive approach to team work, continuous improvement and cost-reduction.
• Complete reports and documentation as required.
• Start up of aseptic manufacture.
• Participations in the validation and qualification procedure of aseptic production including all qualification stages.

Pharmstandart-Ufavita, Russia
Lead process engineer

Responsibility:
• Start up of Insulin production
• Innovative activity of production technology of Insulin.
• Development of production standards of QMS, procedure rules, production lists.
• Development and introduction of new technology of insulin preparation, lyophilisation products, multicomponent vitamin drugs.
• Qualification and validation (DQ/IQ/PQ) of aseptic manufactures injection preparations
• Team member in international audit GMP
• Experience in the clean room grades B/A, C, D during 5 years.
• Experience in logistic complex of products cold storage.
2002 - 2003 Chief of Chemical Laboratories:
• Certification of Analytical Laboratories
• This position performs basic complex of laboratory analysis and field tests.
• Tasks included quality assurance and validation of equipment for laboratories
• Quality control of in-process products, finished products acc. Pharmacopeia monographs, State Pharmacopeia and etc.
• Works with state representatives to ensure program compliance and laboratory certifications. This position involves budget planning and compiling of monthly operational information
• Conducts and interprets basic and complex chemical analysis on water and environmental samples. Conducts analysis for various quality control/quality assurance measures