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• Successful track record of over 27 years in global manufacturing, engineering, supply chain, QA, CMC development, and program management.• Extensive experience developing, scaling up and commercializing drugs, biologics, medical devices, and combination products.• Expert people and project manager with extensive experience managing cross-functional teams spanning multiple countries and organizations.• Successfully managed various functional areas in pilot and commercial production facilities, both in house and CMO.• Led organizations through quality compliance upgrades and participated in numerous successful pre-approval inspections (FDA and EMA).• Thorough knowledge of 21CFR 210/211, 21 CFR 820, ISO 13485 as well as TS16949 and ISO 9001 quality standards• Expert in design controls for medical devices and combination products.• Led execution of capital projects in excess of $150MM.• Expert in supply base development, management, contracts administration and negotiations.• Deep experience and understanding of API, sterile dosage form, non-sterile dosage form, medical device and combined products design, development, and manufacturing.• Strong background in business analysis, risk management, strategy development, change management, organizational design, development, and transformation.
Eiger Biopharmaceuticals, Inc.
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Head Of Technical Operations (Cto)Eiger Biopharmaceuticals, Inc. Apr 2022 - PresentAs Head of Technical Operations Mr. Kurtz is responsible for CMC Development, Manufacturing, Analytical Methods Development, Quality Control, and Supply Chain for both clinical and commercial products. His team manages biologics, small molecules, and drug device combination products from conception to commercialization. His responsibilities also include global sustainability, environmental health and safety and supply chain risk management.
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Head Of Technical Operations (Evp)Cidara Therapeutics Dec 2020 - Apr 2022San Diego, Ca, UsOversee CMC development of injectable small molecules and biologics in the anti-infectives space. Manage the manufacturing and supply chain there-of. Prepare for and execute global regulatory submissions, health authority inspections, and product launches. Ensure product, people, processes and systems are in place to support ongoing commercial production of pharmaceutical products. -
Head Of Commercial Api ManufacturingGilead Sciences Nov 2016 - Dec 2020Foster City, Ca, UsManaged global supply chain for all Gilead commercial API and chemical manufacturing, with peak spending of over $1.1 Billion annually. Led the consolidation and optimization of the worldwide supply base down from over 250 suppliers to less than 100. Implemented companywide supply chain risk management program. Implemented the company’s first S&OP process for API. Implemented cost savings and avoidance programs that returned over $400M to the business over 3 years. Led and developed a team of over 40 people with responsibility for MFG, supply chain, logistics, global tax and trade management. Developed supply chain cyber-security program. -
Senior ConsultantAction For Results Jun 2016 - Nov 2016Life Sciences Consulting -- Manufacturing, Supply Chain, Quality Systems and New Product Development
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Vice President Drug Device IndustrializationAbbvie Aug 2013 - Jun 2016North Chicago, Illinois, UsLead Product Scale up and Industrialization Projects for Drug Device Combinations. -
Manufacturing And Supply Chain ConsultantDance Pharmaceuticals Mar 2013 - Jun 2013Medical device supply chain development
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ConsultantAllergan Oct 2012 - Jun 2013Dublin, Coolock, IeManufacturing and Supply Chain support. CMC development leader for Product Supply Team -
Vp Mfg And Supply ChainSea Medical Sep 2012 - Jun 2013Manufacturing and Supply Chain Strategy development for pure medical device start-up
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Manufacturing And Supply Chain Development For Cell Therapies Company - OncologyPrima Biomed Ltd Jun 2012 - Jun 2013Conduct facilities design and outsourcing assessment. Select CMOs globally for phase III and commercial programs. Assist with tech transfer and comparability studies
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Vp Manufacturing And Global Supply ChainIntelliject May 2011 - Apr 2012
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Vice President Global Supply Chain And Manufacturing OperationsAlexza Pharmaceuticals Jun 2008 - May 2011Fremont, California, UsHead of Global Supply Chain, Engineering, Facilities, Purchasing and EH&S. -
Vice President Of Research And DevelopmentNovo Nordisk Delivery Technologies Jan 2008 - May 2008Bagsværd, DkHead of business unit responsible for all functions including R&D, QA, QC, Supply Chain, Finance, IT, HR and business support. Responsible for organizational transformation after major business unit restructuring. -
Director, Pharmaceutical Manufacturing And DevelopmentNovo Nordisk Delivery Technologies Jun 2006 - Jan 2008Bagsværd, DkDepartment Head of Pharmaceutical MFG and Development team. Managed process/product development and clinical manufacturing activities. Responsible to provide production team and engineering support for aseptic clinical manufacturing, process development, product development, and commercial scale-up. Developed and managed expense/capital budgets of$10M- $20M per annum. Led group of over 155 engineers, manufacturing associates, and contract support staff. Played significant role in strategic capacity analysis and associated capital projects definition. Key player in the organizational development effort for a rapidly expanding business unit. -
Senior Director, Process EngineeringAlza Corporation Jan 2006 - Jun 2006Seattle, Washington, UsDepartment Head of Implant Development team. Managed process/product development and clinical manufacturing activities. Responsible to provide production support for aseptic clinical manufacturing, process development, product development and scale-up. Developed and managed expense/capital budgets $5-10M per annum. Led design controls efforts, IND generation and phase III planning. Led team of over 30 engineers, manufacturing and support staff. Developed and executed a plan to spin off the product line and the implant development team to a third party. Executed plan and initiated the transition.Relevant Unit Operations:Component sterilizationSpray DryingFormulationFilling and packagingAseptic processing -
Director, Operations Engineering, Director Manufacturing EngineeringNektar Therapeutics Inc Sep 2001 - Jan 2006Department Head of Product Commercialization and Sustainment team. Managed product development and commercialization activities. Responsible for production support for both clinical and commercial manufacturing across multiple product lines and processes. Managed Process Engineering, Filling and Packaging Engineering, Controls Engineering, Industrial Automation, and Tooling/ Molding Engineering groups. Developed and managed expense/capital budgets $5-10M per annum. Specified, procured, installed, commissioned, and validated process equipment. Developed layouts and P&IDs. Developed corporate engineering design and project controls policies, and assisted in optimizing the validation program. Built group from four engineers to ~20 inclusive of contract resources.Relevant Unit Operations:Spray DryingPowder filling and packagingTooling, molding, and metal component manufacturing for medical deviceMedical device automated assemblySterile filtrationEmulsion preparationFormulation and stabilization
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Product Commercialization Manager / Senior Process EngineerPowderject Pharmaceuticals Plc Jul 1999 - Sep 2001As Commercialization Manager, responsible for all aspects of commercializing a completely novel powder injection system. Responsible for managing the Clinical Manufacturing Group (a team of ~24) and providing clinical supplies for a variety of product lines. Managed various work streams for the company's lead product which include: Process Engineering, Manufacturing, Quality Assurance, and Quality Control. Responsible for all aspects of project and departmental planning, staffing, budgeting, developing and executing production schedules, providing engineering support, as well as process definition and development.As Senior Process Engineer, supported process definition and scale-up. Products included small molecules, therapeutic proteins, and conventional vaccines.Relevant Unit Operations:Solids handlingSolids classificationMedical Device development and manufacturingLyophilizationAseptic manufacturingClean-room operationsBuffer exchange ultrafiltration for vaccinesVarious particle formation systems and approaches (spray drying, compression/milling/classification schemes, etc.)
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Project Manager / Lead Project EngineerMonsanto Inc.; Nsc Technologies Division Apr 1998 - Jul 1999As Project Manager, scaled-up and commercialized three pharmaceutical intermediate products (primarily chirally pure amino acid derivatives, both synthetically and biologically derived). Selected contract manufacturing sites, negotiated contract manufacturing agreements, procured all raw materials, designed and supervised plant reconfigurations, instituted all safety systems, assisted staff in developing production records, approved all documentation, supervised commissioning and start-up.As Lead Project Engineer, responsible for managing the design and construction of a 150,000 sq. ft. bulk pharmaceutical manufacturing plant. Selected the engineering and construction contractor (Fluor Daniel Inc) and coordinated and approved all aspects of the detailed plant design, (including site design, equipment selection, P&ID’s, architectural design, materials and personnel flow, control systems, and safety systems).
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Plant Engineer / Process Development EngineerHauser Chemical Research May 1995 - Apr 1998As Plant Engineer, responsible for all plant engineering functions including systems design and installation, providing production support, facilities engineering, and maintenance management.As Process Development Engineer, commissioned new manufacturing facility, developed and qualified novel manufacturing processes (primarily naturally derived and isolated pharmaceutical actives). Scaled up, developed, qualified, and validated second-generation Taxol manufacturing process. Designed, constructed, commissioned, and qualified an extremely novel two-phase down-flow tubular oxidation reactor.
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Engineering Watch SupervisorUnited States Navy, Submarine Force Jan 1986 - Jan 1992Responsible for operating, maintaining, and troubleshooting an operational nuclear propulsion system. Managed the Nuclear Machinery Division (staff of 14). Functioned as Senior Quality Assurance Inspector. Shift Supervisor for the de-fueling and decommissioning of the nuclear power plant. Managed numerous refit activities, planned and emergency repairs of over 100 interrelated complex fluid and mechanical systems.
Christopher Kurtz Education Details
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University Of Colorado BoulderChemical Engineering -
Westinghouse S3G Nuclear Engineering ProgramNuclear Power Plant Engineering -
Naval Nuclear Propulsion SchoolNuclear Power -
Nuclear Power School - Naval Nuclear Power Training Command (Nnptc)Nuclear Propulsion Engineering
Frequently Asked Questions about Christopher Kurtz
What company does Christopher Kurtz work for?
Christopher Kurtz works for Eiger Biopharmaceuticals, Inc.
What is Christopher Kurtz's role at the current company?
Christopher Kurtz's current role is Skilled CMC Development, Manufacturing, and Supply Chain Executive.
What is Christopher Kurtz's email address?
Christopher Kurtz's email address is fs****@****hoo.com
What is Christopher Kurtz's direct phone number?
Christopher Kurtz's direct phone number is +144081*****
What schools did Christopher Kurtz attend?
Christopher Kurtz attended University Of Colorado Boulder, Westinghouse S3g Nuclear Engineering Program, Naval Nuclear Propulsion School, Nuclear Power School - Naval Nuclear Power Training Command (Nnptc).
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