As the head of MSAT, I oversee all the technical aspects of drug substance production at Sanofi's Swiftwater site and its CMO partners. My responsibilities include regular commercial support, problem-solving, life-cycle management, process development, technical transfer, facility/equipment design, and process validation for all operations at Swiftwater and related CMO production partners.I lead a team of more than 65 laboratory, engineering and senior technical staff who support vaccine and drug substance manufacturing at Sanofi. Some of the key accountabilities of the MSAT team are:- Conducting annual strain surveillance, selection, characterization, and commercialization activities for seasonal influenza vaccine manufacture for Fluzone® (egg based) and Flublok® (recombinant baculovirus based) products. - Providing technical support, continuous improvement and lifecycle management for the site's bacterial (Meningitis), baculovirus and viral Yellow Fever (egg based) vaccine manufacturing platforms. - Designing, constructing and starting up new Baculovirus and MF59 Adjuvant manufacturing facilities at the site. These facilities are in qualification to support Flublok®, and the future Panblok® pandemic influenza vaccine being developed in partnership with the US – Health and Human Services: department of Biomedical Advanced Research and Development Authority (BARDA). - Collaborating closely with operation, supply chain, finance and commercial operations to ensure that the processes are in-control and capable of meeting current and future business objectives.

Accountable for leadership and oversight of Bulk Manufacturing facilities at the CSL Kankakee site, including: Zemaria® Drug Product, Coagulation Facility (initial plasma fractionation, and Mononine® Drug Production), as well as, Berinert®, and Beriplex® Drug Product Intermediate manufacturing facilities. Accountable for providing leadership of 230+ operational and technical staff involved in intermediate and drug substance manufacturing at the site. Responsible for providing strategic direction required to meet global demand of intermediate and finished goods and for driving process improvements/efficiency efforts within these facilities with a specific focus on enhanced GMP and financial savings.

Joined Seqirus organization as part of CSL acquisition of Novartis Influenza Vaccines.Accountable for leading multiple simultaneous Technical Transfers associated with establishment of the new Seqirus global supply network, including the following products/process: Fluad® Trivalent, Fluad® Quadravalent, Agrippal®, Agriflu, Aflunov® Pre-pandemic Foclivia® Pandemic, MF59® Adjuvant, along with the associated material manufacture (buffers, antibiotics and media).Accountable for planning and execution Technical Transfer associated with the exit of Fill Finish operations from the Novartis legacy manufacturing site in Rosia, Italy (now GSK owned), to the Seqirus Liverpool, U.K, Holly Springs, NC and CSL-Behring, Germany facilities, in addition to the identification, auditing, on-boarding and Technical Transfer for Fill Finish Operations to multiple Contract Manufactures (CMOs) in Europe. Projects include construction of a new Parenteral Formulation, Filling, Inspection and Secondary Packaging capabilities for pre-filled syringes and multi-does vials at the Liverpool site. Technical Transfer of MF59 Adjuvant manufacturing capabilities from Marburg, Germany to Liverpool, U.K.

Accountable for leadership of the Holly Springs site MS&T organization (~60 Staff) providing annual strain surveillance, selection, characterization, and commercialization activities for the industries only cell-culture based flu vaccine (Flucelvax®). Accountable for the technical support and continuous improvement of sites on-going Drug Substance and Drug Product commercial operations. Additional responsibilities include, process and analytical development, technical transfer, facility/equipment design, and process validation activities associated to all commercial operations at site. Integral member of site leadership team. Note: As of Aug-2015 Organization is in the process of merger with bioCSL® to form Seqirus®, a CSL Company

Accountable for providing technical leadership for remediation, revalidation and restart of Novartis’ bulk manufacturing facilities in Rosia, Italy following the discovery of significant quality issues that resulted in the company voluntarily suspending commercial operations at the site. In Q4-2012, assumed position of MS&T Head for Novartis Italy on an Ad Interim basis to continue supporting the ongoing restructuring efforts within Novartis’ Italian manufacturing sites. In this role, I led a multi-site MS&T organization supporting ongoing development and commercial operations and was an integral part of the transitional site leadership team. This assignment was successfully completed in Q3, 2013 following, my recruitment and on-boarding of two permanent department head’s to lead the MS&T organizations supporting Drug Product and Drug Substance Manufacturing at the site.In parallel with the above responsibilities, I also lead the MS&T function supporting the Design, Construction, Technical Transfer and Startup of the Pernambuco Biotech Manufacturing facility in Recife, Brazil. In this role, I was accountable for the technical transfer of the bulk production process for the three Bexsero® recombinant protein antigens into the facility, and for recruitment, training, establishment of a new site MS&T organization to support future commercial operations. Project placed on hold at the 80% milestone and staff redeployed following divestment of the Novartis Vaccines division (not including Flu products) to GSK.

Provided management and technical leadership for the Purification Process Engineering (PE) function. Manager for a team of Engineers and Scientists providing technical support for the process development, process characterization, facility/equipment design, technical transfer for new products into the facility, and on-going commercial support for downstream operations with the facility.Accountable for leading process final validation and commercialization phases related to the start-up of the new Mammalian Cell-Culture production facility (AML-6) for production of Aranesp® (darbepoetin alfa). Technical Lead for >$500M purification capacity increase expansion of facility. Technical Transfer Lead for the successful introduction of the Prolia® (denosumab) and Epogen® (epoetin alfa) manufacturing processes into the facility.

Provided Technical Transfer leadership for all aspects of Lilly's newest >$800M Humalog® Bulk Manufacturing Facility in Carolina, Puerto Rico. At time of construction this facility was considered one of the world's largest biotech facilities. The facility was constructed, validated, and approved by the U.S. Food and Drug Administration in four years, and granted fast-track approval by other regulators. In its second year of operation, the plant received classification as an OSSCE Class A site—well ahead of the industry benchmark.Supported the engineering, construction, fabrication, shipment, field installation and quality oversight for the 100,000 sq. ft. Fermentation/Isolation manufacturing facility and the 211,680 sq. ft. Purification Facility, which utilized modular construction techniques, consisting of 589 total process modules fabricated in 4 different countries with final assembly and finishing in Puerto Rico.Functioned as the process technical interface between internal user groups, Fluor Daniel Process Engineering, Lilly Senior Management and Quality Control for the conceptual and schematic design of new Humalog® Manufacturing Facility.

Managed a downstream technical support team for the Humalog® manufacturing process: Responsibilities included maintaining development of batch records, SOP’s, maintaining and improving process product quality, cycle-time, throughput, Non-conformance and root-cause investigations and managing laboratory and floor support personnel.Provided technical support and direction for three large-scale capacity and quality upgrade projects, these included scale increase in both bulk volume and chromatography (2M scale-up) operations, also responsible for the implementation of Lilly first large scale pack-in-place chromatography systems.