Paul Voronko Email & Phone Number

Responsible for developing the network strategy and ensuring a reliable supply of biologics to support Clinical Trails. • Directed staff in supporting the production of biologics (monoclonal antibodies, proteins, and cell therapy products) at contract manufactures (CMO’s) to meet the needs of clinical programs.• Developed 10 yr demand projections for clinical and commercial manufacturing capacity. Analysis resulted in the approval of a $6.9 million capital investment in additional… Show more Responsible for developing the network strategy and ensuring a reliable supply of biologics to support Clinical Trails. • Directed staff in supporting the production of biologics (monoclonal antibodies, proteins, and cell therapy products) at contract manufactures (CMO’s) to meet the needs of clinical programs.• Developed 10 yr demand projections for clinical and commercial manufacturing capacity. Analysis resulted in the approval of a $6.9 million capital investment in additional bioreactor capacity for clinical production.• Worked with Finance and Engineering on a make vs buy analysis for the production of biologics at commercial scale. Work resulted in management approval to move forward with developing Engineering estimates for building a commercial scale facility.• Established a process for evaluating CMO’s for development and clinical manufacturing of biologics. • Developed a sourcing strategy for internal vs external API clinical manufacturing.• Developed cost estimates for new products. Ensured that costs adhered to program budgets.• Partnered with Quality in supporting audits at new CMO’s. Leveraged professional network for addressing any subsequent remediation activities required for GMP manufacturing.• Partnered with Procurement and Legal in developing contract terms for manufacturing supply agreements. Negotiated reductions in the required timeframes for reserving capacity and cancellation penalties.• Partnered with management at various CMO’s to put in place quarterly Joint Steering Committee meetings. Developed Scorecard metrics for evaluating Supplier performance in meeting production milestones, financials, and quality. Show less

• Secured approval of $17.4 million in capital for the expansion and retrofit of the manufacturing facility to meet FDA standards and the ability to pass a site Pre-Approval Inspection.• Interacted with the FDA to discuss the facility upgrades and the planned submission package.• Led the site team thru 2 successful Centers for Disease Control (CDC) inspections that resulted in re-licensure of the facility to manufacture toxin.• Identified and secured the resources from within J&J to… Show more • Secured approval of $17.4 million in capital for the expansion and retrofit of the manufacturing facility to meet FDA standards and the ability to pass a site Pre-Approval Inspection.• Interacted with the FDA to discuss the facility upgrades and the planned submission package.• Led the site team thru 2 successful Centers for Disease Control (CDC) inspections that resulted in re-licensure of the facility to manufacture toxin.• Identified and secured the resources from within J&J to fill in the missing experience and on-site knowledge required for development and commercialization of a biologic product.• Put a Leadership Team in place and developed a Site Cascade that drove individual Goals & Objectives.• Managed Finance and HR issues with no on-site support. Prepared and managed an operating budget of $17 million. Executed a site reorganization plan, identified and put in place development opportunities for staff, and addressed performance issues as needed.• Improved Communications and Rewards & Recognition in response to Credo survey feedback.• Increased site focus on Safety. Hired an EHS professional for the site, implemented regular Safety Committee meetings, helped to develop an action plan to address safety gaps, and implemented a Near Miss reporting program.• Led teams for addressing technical problems and resolving supplier issues.• Worked with legal in developing contracts for supplying goods or services.• Member of the integration team that worked to bring in standard J&J systems and processes to the site; the Compound Development Team that guides the overall toxin program; and the CMC team that directly manages product and process activities.• Received J&J’s 2010 Supply Chain Collaboration Excellence award in recognition of efforts to successfully bring Pharmaceutical expertise into a Medical Device Company. Show less

• Reduced the cost-of-goods of commercial products by >$3.5 million in 2009 through the implementation of process improvements.• Managed a portfolio of projects expected to yield savings of >$18 million. Implemented a project review and resource allocation system to ensure that resources were being deployed to activities having the greatest impact on the business.• Executed 11 Drug Substance development batches in 2009. The runs represented 5 different monoclonal antibodies… Show more • Reduced the cost-of-goods of commercial products by >$3.5 million in 2009 through the implementation of process improvements.• Managed a portfolio of projects expected to yield savings of >$18 million. Implemented a project review and resource allocation system to ensure that resources were being deployed to activities having the greatest impact on the business.• Executed 11 Drug Substance development batches in 2009. The runs represented 5 different monoclonal antibodies produced by either perfusion or fed batch technology.• Delivered 18 Drug Product batches in 2009 for Phase 1 / 2 Clinical Trials.• Installed a $1.7 million Vaporized Hydrogen Peroxide facility decontamination system. Project was executed in 8 weeks and eliminated less reliable manual decontamination methods.• Transferred small scale filling capacity from the US to Switzerland. Project avoided increased costs of having fills outsourced to a contract facility.• Conducted full scale studies evaluating bioreactor design and process operating conditions in parallel to the construction of a commercial facility in Cork, Ireland. Final design recommendations were implemented at the new facility and bioreactor operations were brought on-line with no “surprise” start-up issues.• Provided technical input during the investigation, resolution and implementation of corrective actions to address process deviations.• Reviewed regulatory submissions and assisted in preparing responses to audit observations.• Led a cross-functional team in conducting a make-vs-buy decision analysis for generating Phase 3 Clinical supplies of small volume biologics.• Led a cross-functional team charged with identifying opportunities to harmonize the production processes for New Molecular Entities. • Drove integration of site Technical Support groups into a global organization that increased resource efficiency by leveraging technical expertise across multiple sites. Show less

Directed a staff of 170 in the Manufacturing (cell culture, Protein A purification, media preparation, and equipment preparation), Technical Support, and Compliance operations for the production of a monoclonal antibody.• Managed the production of 400+ kg/yr of Centocor’s flagship monoclonal antibody (Remicade®).• Member of the site leadership team. Participated in development of an overall Business Plan for the site by providing direction for strategic capital projects, allocating… Show more Directed a staff of 170 in the Manufacturing (cell culture, Protein A purification, media preparation, and equipment preparation), Technical Support, and Compliance operations for the production of a monoclonal antibody.• Managed the production of 400+ kg/yr of Centocor’s flagship monoclonal antibody (Remicade®).• Member of the site leadership team. Participated in development of an overall Business Plan for the site by providing direction for strategic capital projects, allocating limited resources to projects having the greatest impact, responding to employee issues, and setting site policies.• Utilized production metrics to trend performance and aid in the identification and correction of manufacturing and quality issues.• Ensured the development of a leadership pipeline by identifying high potential employees, putting in place formal Development Plans, and providing opportunities for development of technical and managerial skills.• Participated in Business Development and due-diligence activities to evaluate acquisition, licensing or partnership opportunities.• Worked with Finance to develop and manage the department’s $23 million expense budget. Show less

Directed a staff of 100+ Engineers and Technologists in the concurrent goals of technology transfer, process scale-up, and facility start-up. Managed the Technical Support, Automation, Engineering, and Facilities Maintenance departments to provide overall GMP support for a monoclonal antibody production facility and 3 pilot plants.• Member of the management team responsible for the final design, construction, and start-up of a 120,000 ft2 / $100 million antibody production… Show more Directed a staff of 100+ Engineers and Technologists in the concurrent goals of technology transfer, process scale-up, and facility start-up. Managed the Technical Support, Automation, Engineering, and Facilities Maintenance departments to provide overall GMP support for a monoclonal antibody production facility and 3 pilot plants.• Member of the management team responsible for the final design, construction, and start-up of a 120,000 ft2 / $100 million antibody production facility.• Performed a detailed process comparison between manufacturing sites (US / The Netherlands) and identified the differences in process equipment and production methods. Designed the studies to show comparability of the product manufactured from both sites.• Designed, authored, and coordinated the execution of the Process Validation studies. Wrote and / or reviewed the entire CMC section of the Regulatory Submission.• Presented validation data and addressed FDA and EMA questions during Pre-Approval Inspections.• Developed and managed the department’s expense ($15 million), capital ($14 million), and utility ($2 million) budgets.• Received J&J “Standards of Leadership” award in recognition of contributions that resulted in facility approval 5 months ahead of schedule. Show less

Directed a staff of 40 technicians in the cell culture, protein purification, and media preparation operations for production of recombinant human growth hormone (r-hGH) in an automated roller bottle facility.• Improved Cell Culture productivity 50% and Protein Purification yields 15% as a member of an international team to design experiments, interpret data, and implement process changes.• Prepared for and passed FDA (US), EMA (European), and HPB (Canadian) facility… Show more Directed a staff of 40 technicians in the cell culture, protein purification, and media preparation operations for production of recombinant human growth hormone (r-hGH) in an automated roller bottle facility.• Improved Cell Culture productivity 50% and Protein Purification yields 15% as a member of an international team to design experiments, interpret data, and implement process changes.• Prepared for and passed FDA (US), EMA (European), and HPB (Canadian) facility inspections.• Managed the production of recombinant human interlukin-6 (r-hIL-6) using a packed bed bioreactor to support clinical trials. Coordinated efforts to retrofit existing equipment, design and construct new systems, and validate equipment.• Determined cost and time estimates for the production of recombinant human follicle stimulating hormone (r-hFSH) using a spinfilter bioreactor. Worked with a contract manufacturer on the retrofit of equipment, design specifications for new bioreactors, and technical transfer of process. Show less

Managed the operation of a pilot plant with 25 fermentors ranging in size from 60 to 4700 liters. Supervised a staff of 7 technicians. Directed a microbial research program to improve and support commercial manufacturing operations. Provided technical support for a cell culture operation producing material for clinical trials.• Upgraded bioreactors for use in plant and animal cell culture.• Designed, budgeted, and managed the construction of a $1 million cell culture… Show more Managed the operation of a pilot plant with 25 fermentors ranging in size from 60 to 4700 liters. Supervised a staff of 7 technicians. Directed a microbial research program to improve and support commercial manufacturing operations. Provided technical support for a cell culture operation producing material for clinical trials.• Upgraded bioreactors for use in plant and animal cell culture.• Designed, budgeted, and managed the construction of a $1 million cell culture suite.• Participated in the review and modification of P&IDs for a new $30 million cell culture plant.• Initiated a facility renovation program and directed the progress. Identified, budgeted, and coordinated instrument upgrade projects to enhance process consistency. Show less

Utilized a production capacity exceeding 1 million gallons for the scale-up and production of antibiotics, organic acids, biopolymers, enzymes, and flavorings.• Implemented cost improvement projects totaling $1.4 million.• Designed, developed budgets, and met strict timelines for capital projects up to $500,000. Designed piping layouts, selected instrumentation and equipment.• Generated cost estimates for new products.

Master Of Science - Ms, Chemical Engineering

Thesis: Immobilization of Penicillium chrysogenum on porous supports using a latex polymer.

Bachelor Of Science - Bs, Biology, General