George H. James Email and Phone Number
Severus Engineering | Launch Date Protection Specialist to Eli Lilly - Lebanon API Project at
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Eli Lilly and Company
Indianapolis, IN, US
George H. James's Location
Bloomington, Indiana, United States, United States
George H. James's Contact Details
George H. James work email
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George H. James personal email
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George H. James phone numbers
About George H. James
My career has focused on developing and deploying best-in-class performance in engineering, manufacturing and supply chain. I have enjoyed building and guiding teams of people across the world who achieve exceptional results.When I'm not at work, I enjoy golfing, shooting pool (both of which are still in need of improvement), and time with family and friends. I'm passionate about causes that promote patient health, maximize human potential, and unite people for positive change in the spirit of unity, teamwork and excellence.
George H. James's Current Company Details
Eli Lilly And Company
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Severus Engineering | Launch Date Protection Specialist to Eli Lilly - Lebanon API Project
Indianapolis, IN, US
George H. James Work Experience Details
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Severus Engineering | Launch Date Protection Specialist To Eli Lilly - Lebanon Api ProjectEli Lilly And CompanyIndianapolis, In, Us
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Principal Consultant | Severus Engineering | Consulting Partner To Eli LillyEli Lilly And Company Dec 2024 - PresentIndianapolis, Indiana, Us• Managing cross-functional teams to ensure on-schedule, on-budget operational readiness for the Lebanon API facility, integrating deliverables across all functional areas.• Streamlining site startup planning and execution, aligning operational readiness schedules with construction and qualification timelines to meet project milestones effectively.• Partnering with leadership and frontline teams, leveraging broad knowledge and cross-functional collaboration to drive seamless project delivery for a high-impact, large-scale facility.
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Director, Engineering, Biopharma Solutions (Now Simtra)Baxter International Inc. Nov 2021 - Nov 2024Deerfield, Illinois, UsSite engineering lead for one of the largest contract manufacturers of sterile products in North America, with a state-of-the-art 600,000-square-foot campus. As a full-service contract manufacturer, the Bloomington facility serves client needs with clinical development through commercial launch. These include manufacturing, packaging, quality systems, experience with worldwide regulatory agencies, and lyophilization expertise with our Lyophilization Center of Excellence. -
Site Engineering DirectorGsk Aug 2020 - Aug 2021Brentford, Middlesex, Gb- Successfully led a multi-million design, construction, installation, commissioning, and qualification of a formulation suite. This suite included installing a multi-ton stainless steel mixing vessel inside an existing building and other high-hazard activities. This project is on track for timely, under-budget completion, with 30,000+ person-hours worked without a lost-time injury. - Led the major retrofit of a multi-ton formulation system to accommodate increased capacity.- Oversaw the planning for a future multi-year expansion of one of the most advanced operations of its kind in the world. - Successfully led team that delivered multiple OEE improvements using the TPM methodology to drive improved performance rates on the packaging lines and reduced batch cycle times in the manufacturing area.- A member of the Site Leadership team, oversaw all engineering activity, including Process Engineering, Electrical Engineering, Process Automation, Maintenance, Facilities, Spare Parts, and Capital Projects. The site manufacturers Sensodyne and other oral care products for the US Market. -
Director, Manufacturing OperationsCresilon Nov 2016 - Aug 2020Brooklyn, New York, Us- Successfully designed, constructed, commissioned, qualified and operated a one-of-a-kind and the only aseptic fill-finish facility in New York City, U.S.A. This innovative fill, finish and packaging faculty is housed in a 100-year old building complex listed in the U.S. National Register of Historic Places.- Led all aspects of aseptic cGMP manufacturing operations including production, supply chain (materials handling, purchasing, shipping, receiving, warehousing), facility design/start-up, and process development/transfer.- Played a pivotal role in fundraising to produce, test, and commercialize Cresilon's flagship product VETIGEL™, a plant-based gel technology for hemostasis. -
Aseptic Manufacturing - Independent ConsultantIntarcia Therapeutics, Inc. Jul 2016 - Nov 2016Boston, Ma, UsProvided program management and expertise in cleaning and sanitization of Intarcia's Aseptic Processing Areas in preparation for the launch of the ITCA 650 / Medici Drug Delivery System. -
Director, Facilities Systems And Plant EngineeringGenentech Mar 2014 - Jun 2016South San Francisco, California, Us- Guided the successful improvement of Genentech's 60 buildings, 6 million square feet of office, laboratory research, development, and cGMP manufacturing site. - Led improvements of the campus' 300,000-point automation system and infrastructure, avoiding wasteful activities and costly workarounds. - Led an energy team that has reduced site energy and water consumption every year since its inception.- Supported several successful inspections by the FDA and other agencies in several areas, including facility compliance, laboratory and manufacturing supplies, spare parts, equipment instrumentation, calibration, and other information critical to the compliant operation of one of the largest sites on the west coast. -
Director, Worldwide FacilitiesIdexx Laboratories Jan 2013 - Mar 2014Westbrook, Maine, Us- Led the Maintenance, Facilities Management, Capital Projects, Real Estate and EHS teams supporting 62 sites across five continents. - Led the construction of a $35 million three-story, 108,000-square-foot science and research facility. The facility has been designated as a LEED Gold building by the U.S. Green Building Council. -
Vp, Global Operational ExcellenceBiogen Idec Dec 2009 - Jan 2011Cambridge, Ma, Us- Implemented innovative practices such as Lean Six Sigma. Led projects that transformed Biogen's multi-billion manufacturing and logistics operations across the world.- Assembled and led “rapid deployment” teams that identified and prioritized 83 problems in the finished goods to distribution end of the supply chain. Completed the most critical projects within a year. -
Vp, Global OperationsBiogen Idec Dec 2008 - Nov 2009Cambridge, Ma, UsPromoted to oversee Biogen's commercial and clinical drug supplies. Developed and successfully implemented strategic plans for supply to direct commercial operations in 25 countries and distributor operations in 70 countries. Oversaw the effective planning, delivery and tracking of clinical supplies for 28 clinical trials, 1,500+ sites in 20 countries. Trials proceeded without a single “stockout.”Transformed practices and processes for global organization affecting a matrix organization of over 2,000 employees and contractors across the Pharmaceutical Operations and Technology Division.Reorganized and optimized the supply chain through a 400% single year increase in packaging and shipment volumes in support of a rapid launch of new products.Consolidated suppliers supporting an outsourced small molecule supply chain.
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Sr. Director, Global Engineering And FacilitiesBiogen Idec Dec 2007 - Nov 2008Cambridge, Ma, UsPromoted to run engineering, maintenance, Environmental, Health and Safety and facilities services to all Biogen facilities in US and Europe.
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Director, Cambridge FacilitiesBiogen Idec Dec 2006 - Nov 2007Cambridge, Ma, UsResponsible for engineering, maintenance, Environmental, Health and Safety and facilities services to the Cambridge, Massachusetts US campuS, including Manufacturing, Administrative and Research / Development building. Services included the campus’ 5.7 mega-watt cogeneration plant.
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Regional Manager, Maintenance ExcellenceJohnson & Johnson Nov 2004 - Nov 2006New Brunswick, Nj, Us- Achieved award-winning performance in maintenance by optimizing work planning, inventory management and reliability of critical equipment.- Pioneered methods that improved Overall Equipment Effectiveness (OEE) and reduced Mean Time Between Failures (MTBF) of critical manufacturing equipment. -
Manager, Facilities EngineeringJohnson & Johnson Nov 2003 - Oct 2004New Brunswick, Nj, Us- Led the reorganization of two engineering and maintenance teams. Saved $1.3 million in costs with no regrettable losses. Received the Johnson & Johnson’s “Standards of Leadership” award for demonstrating “exemplary leadership” in the project. - Successfully reconfigured 34,000 sq.ft. of manufacturing and laboratory space, offsetting costs by $2.0 million. Relocated two pilot plants, a technology transfer lab and a Biohazard Level 2 (BL2) manufacturing facility.- Revamped a critical master cell bank used in manufacturing and research. Upgraded equipment and improved operations and change control procedures. Converted the cell bank’s 25,000 manual records to an electronic database that contained 30+ years of irreplaceable donor red cells.- Developed and trained teams to implement a new system to plan and execute capital projects. This led to $1 million dollars in savings, tighter scope management and more effective financial controls.
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Manufacturing Engineering ManagerJohnson & Johnson Nov 2002 - Oct 2003New Brunswick, Nj, UsResponsible for providing engineering support to the RhoGAM, BioVue and Donor Screening manufacturing lines, a 24/7 manufacturing operation.Co-authored a recovery plan for the supply chain that became the model for Johnson & Johnson sites worldwide. Conducted “table top” testing of emergency readiness and successfully trained company leaders. -Directed two projects that improved waste handling in the RhoGAM and Biovue manufacturing. These projects delivered over $140,000 in savings per year.- Established dialogue with manufacturing in support of the BioVue and RhoGAM manufacturing lines. This effort set forth a pathway for continued progress and improved strained relationships between engineering and manufacturing operators and supervisors.
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Environment, Health And Safety Manager - Ortho Clinical DiagnosticsJohnson & Johnson Nov 2001 - Oct 2002New Brunswick, Nj, UsLed effort culminating in an ISO14001 registration, opening new products to European markets. Negotiated resolution of significant compliance issues plaguing facility.
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Manager, Ehs ServicesLfr Levine Fricke (Now Arcadis) Jul 1998 - Nov 2001
George H. James Skills
Six Sigma
Cross Functional Team Leadership
Gmp
Lean Manufacturing
Manufacturing
Biopharmaceuticals
Quality System
Biotechnology
Strategic Planning
Fda
Change Management
Continuous Improvement
Supply Chain
Technology Transfer
Engineering Management
Contract Manufacturing
Capa
Medical Devices
Team Leadership
Process Engineering
Supply Chain Management
U.s. Food And Drug Administration
Scrm
Iso
Quality Management
V&v
Quality Auditing
Global Business Development
Business Transformation
Rcm
Toyota Production System
Construction Management
Corrective And Preventive Action
Leadership
Supply Chain Risk Management
Fmeca
Predictive Maintenance
Reliability Engineering
Oee
Iso 14001
Verification And Validation
Owner's Representation
Pareto Analysis
Bioremediation
Process Validation
Compliance Audits
Aseptic Manufacturing
Project Management
Program Management
Lean Management
George H. James Education Details
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Rensselaer Polytechnic InstituteChemical Engineering -
Business Process RedesignAnd Impacts
Frequently Asked Questions about George H. James
What company does George H. James work for?
George H. James works for Eli Lilly And Company
What is George H. James's role at the current company?
George H. James's current role is Severus Engineering | Launch Date Protection Specialist to Eli Lilly - Lebanon API Project.
What is George H. James's email address?
George H. James's email address is ge****@****zon.net
What is George H. James's direct phone number?
George H. James's direct phone number is +120144*****
What schools did George H. James attend?
George H. James attended Rensselaer Polytechnic Institute, Business Process Redesign.
What are some of George H. James's interests?
George H. James has interest in Economic Empowerment, Potenciamiento Económico, Sailing, Tennis, Golf.
What skills is George H. James known for?
George H. James has skills like Six Sigma, Cross Functional Team Leadership, Gmp, Lean Manufacturing, Manufacturing, Biopharmaceuticals, Quality System, Biotechnology, Strategic Planning, Fda, Change Management, Continuous Improvement.
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