John Mcgee Email & Phone Number

Lead a Team of 100+ professionals with responsibities for Global Facility and Process design and execution.

Lead a Team of 20+ Process Engineers, with accountability for over $2BB of Large Molecule Capital Spend across in-line product expansions and new product launch facilities.Effective recruiter of experienced and developing talent, and key technical contact to Value Chain Management and Integrated Development and Supply Teams.Accomplishments: • Led Early Engagement Teams to translate Portfolio Strategies into Supply Chain / Capital solutions for multiple vaccine and biologics programs including recombinant, bacterial conjugate, micro carrier based LVV, and monoclonal antibodies. • Effectively led the Recombinant Drug Substance Project Portfolio valued at $1.2BB • Led development of a recapitalization scope for an established immune oncology product • Guided discussions with Process Development, R&D, and Tech Transfer Teams for technology selection and scale to improve manufacturability of transferred products across multiple programs most notably • micro-carriers vs cell factories, • Reactor Scale and Sterile Filtration, •Scale vs. Supply Chain Demands and speed to market

Ensure the application of Merck Production System design methods to all Manufacturing Capital Projects through coaching of project teams. Responsible for the development of assigned direct reports as MPS Coaches through development assignments in the COE and ensure efforts are aligned with World Class Supply goals and Model Line method deployment.Major AccomplishmentsDeveloping the MPS COE within GES through collaboration with Global MPS. The COE analyst role is designed as a development position to gain deep knowledge in Lean and Supply Chain Design principles and methods and subsequent transition into other areas with GES, or Merck. COE Alumni have effectively transitioned into Process Engineering, MMD IT, and USHH. Significant Project Engagements across Biologics, Vaccines, and Pharma projects to apply Lean Manufacturing and World Class Supply Principles and methods.Launch of the Engineering Virtual Technical Network - a platform which permits knowledge sharing and problem solving within the Merck Engineering Community around the globe.

Dedicated Lean Six Sigma Leader responsible for LSS Deployment across GES, which reached 90% across GES, and application of LSS methods to targeted GES projects and significant Organizational Initiatives.Major Accomplishments include: Application of Design for MPS methodology to projects for key products resulting in 25-50% reductions in Capital Investment, Facilitation of the GES Leadership Team through a major organization redesign and implementation of an integrated Tier based Governance Process

Group Leader for the TMO LSS & Modeling Group. Responsible for two modeling CofE direct reports and LSS Implementation for the TMO.Major Accomplishments:Development of the GES Modeling CofE including deployment and management of ProModel Developer & Process Simulator and restructuring of the Aspen Engineering Suite License Agreement.Capital Project Team Lead and Lead Process Engineer for a Live Virus Capacity Expansion. Responsible to guide project through all scope development and subsequent funding reviews. First Capital Project to deploy a Design for MPS approach, which formed the basis for subsequent deployments throughout GES.Direct support - Design for Lean Six Sigma - Active projects included a filling facility in Carlow Ireland (a 2013 ISPE FOYA winner for Operational Excellence), and a live virus manufacturing facility in North Carolina. Sponsored and supported a design approach to inject Lean Thinking into the design basis and ensure that facilities and processes are designed to flowChange Execution Mentor – TMO Transformation - Actively supporting TMO Team responsible to deploy TMO’s staffing model for the “new” MerckVaccine Process Engineering Team Member on award winning Hard Cost Capital Effectiveness Team, a cross functional Team chartered with driving to root cause of high capital hard cost expenses. Solution developed resulted in a 20% reduction in the overall Corporation's Capital Portfolio. The efforts were recognized at the 2005 Annual Merck Operational Excellence Award as the "Best Overall" Op Ex Project for 2005.

Lead Process Engineer responsible for all aspects of Process Engineering, Equipment Design and Automation Integration for assigned projects including Live Virus Vaccines and recombinant yeast products.Major Accomplishments included: Leading a Team of Process Engineers to deliver a 90,000 Sq Ft, $100MM Live Virus Vaccine facility in West Point PA, including deployment of Emerson's emerging Delta-V platform with the first in Merck fully integrated Foundation Fieldbus Instruments and bus based discrete I/O.Leading a Team of Process Engineers through Front End Process Design and Automation Integration for a $50MM fermentation capacity expansion project for recombinant yeast cell paste project, including extensive development of standard Delta-V equipment modules.Change Agent for Capital Effectiveness Soft Cost (Engineering) deployment across VPE.

Lead Process Engineer Vaccine Process Engineering - responsible for all aspects of assigned Capital Projects.Major AccomplishmentsLead Process Engineer for Process Transfer of a microbial antigen product to a CMO in upstate NY. Lead a team of three Merck Engineers and up to 18 contract staff to deliver all Facility, Process, and Automation designs for a complete renovation of an existing facility including fermentation, recovery, and purification process equipment, sterile supply equipment, and waste handling (inactivation and neutralization). Directly supported project from Basis of Design through Demonstration including 18 months of onsite support at CMO and equipment vendor locations. Supported development of the sBLA filing package, including providing engineering support during the CBER Type C meeting and on-site support of the PAI.Lead Process Engineer & Capital Process Lead for Live Virus Vaccine Purification System commercialization. Responsible for all aspects of redesign of second generation purification system to ready the system for commerical vs. development operations. Process included redesign of facility deficiencies, automated CIP & SIP cycles, and the Automation platform while maintaining validated process parameters for the purification process. Coordinated project from Scope development and approval through design, start-up, and support for filing of CBE-30 package.

Responsible for capital installation projects ranging in complexity from simple vessel upgrades to laboratory facilities redesign. Scope of project responsibilities included, scope definition, budget preparation, project scheduling, design and specification of equipment and instrumentation, as well as normal project management issues of cost/schedule control and management reporting.Major AccomplishmentsLead Engineer for $5MM Renovation of Pilot Lab - responsible for all aspects of project scope and execution.Start-up coordinator Small Scale Organics Pilot Plant - Lead Engineer from Resource Management responsible to provide coordination of daily resources and key interface to Central Engineering Management Team during transition from construction to operations for a state of the art pilot plant.Facility renovation Antibiotic Filling Suite - OSD Pilot Plant West Point PA - responsible for all aspects of project scope and execution including room reconfiguration, autoclave retrofit, and refurbished powder filling equipment installation to support pipeline development of novel antibiotics.

Responsible to Project Managers to provide in-house scheduling, cost control, and progress measurement, and ensuring Corporate cost reporting standards were met.Promoted to Senior Engineer while assigned to a $55MM research facility project, responsibilities included design and development of a PC based project cost reporting system (PCRS) for the project, and coordinating access to accounting and materials management data.Upon reassignment to home office, responsibilities expanded to include management of modifications to the PCRS for implementation at all supported sites. This included developing a long-term strategic plan for systems development, managing efforts of four contract programmers;and overseeing installation and implementation of PCRS for projects at sites in Montreal, Pennsylvania and Puerto Rico.

Engineering Service Lead with responsibility for Pilot Plant testing of proposed designs, custom equipment fabrication and on-site start-up and testing support.Major Accomplishments:Commissioning and Start-up of two air pollution platforms for Plattsburg NY Waste Treatment and Composting Facilities. Responsible for FAT of all control cabinets and all aspects of on-site system commissioning, issue resolution, and technician training. Contract values exceeded $1MM for each system.Commissioning and start-up of a modular skid based multi-stage air pollution control system for an experimental hazardous waste incinerator. Responsible for in-house fabrication coordination, control panel integration, and all on-site commissioning of the system which included a tantalum quench, two stage particle scrubber, two stage acid gas scrubber, and a natural gas fired oxidizer. System was fully explosion proof and rated for Class I Div I Group B operations.