Christopher Kurtz

Christopher Kurtz Email and Phone Number

Skilled CMC Development, Manufacturing, and Supply Chain Executive @
Christopher Kurtz's Location
Half Moon Bay, California, United States, United States
About Christopher Kurtz

• 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.

Christopher Kurtz's Current Company Details
Eiger BioPharmaceuticals, Inc.

Eiger Biopharmaceuticals, Inc.

Skilled CMC Development, Manufacturing, and Supply Chain Executive
Christopher Kurtz Work Experience Details
  • Eiger Biopharmaceuticals, Inc.
    Head Of Technical Operations (Cto)
    Eiger Biopharmaceuticals, Inc. Apr 2022 - Present
    As 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.
  • Cidara Therapeutics
    Head Of Technical Operations (Evp)
    Cidara Therapeutics Dec 2020 - Apr 2022
    San Diego, Ca, Us
    Oversee 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.
  • Gilead Sciences
    Head Of Commercial Api Manufacturing
    Gilead Sciences Nov 2016 - Dec 2020
    Foster City, Ca, Us
    Managed 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.
  • Action For Results
    Senior Consultant
    Action For Results Jun 2016 - Nov 2016
    Life Sciences Consulting -- Manufacturing, Supply Chain, Quality Systems and New Product Development
  • Abbvie
    Vice President Drug Device Industrialization
    Abbvie Aug 2013 - Jun 2016
    North Chicago, Illinois, Us
    Lead Product Scale up and Industrialization Projects for Drug Device Combinations.
  • Dance Pharmaceuticals
    Manufacturing And Supply Chain Consultant
    Dance Pharmaceuticals Mar 2013 - Jun 2013
    Medical device supply chain development
  • Allergan
    Consultant
    Allergan Oct 2012 - Jun 2013
    Dublin, Coolock, Ie
    Manufacturing and Supply Chain support. CMC development leader for Product Supply Team
  • Sea Medical
    Vp Mfg And Supply Chain
    Sea Medical Sep 2012 - Jun 2013
    Manufacturing and Supply Chain Strategy development for pure medical device start-up
  • Prima Biomed Ltd
    Manufacturing And Supply Chain Development For Cell Therapies Company - Oncology
    Prima Biomed Ltd Jun 2012 - Jun 2013
    Conduct facilities design and outsourcing assessment. Select CMOs globally for phase III and commercial programs. Assist with tech transfer and comparability studies
  • Intelliject
    Vp Manufacturing And Global Supply Chain
    Intelliject May 2011 - Apr 2012
  • Alexza Pharmaceuticals
    Vice President Global Supply Chain And Manufacturing Operations
    Alexza Pharmaceuticals Jun 2008 - May 2011
    Fremont, California, Us
    Head of Global Supply Chain, Engineering, Facilities, Purchasing and EH&S.
  • Novo Nordisk Delivery Technologies
    Vice President Of Research And Development
    Novo Nordisk Delivery Technologies Jan 2008 - May 2008
    Bagsværd, Dk
    Head 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.
  • Novo Nordisk Delivery Technologies
    Director, Pharmaceutical Manufacturing And Development
    Novo Nordisk Delivery Technologies Jun 2006 - Jan 2008
    Bagsværd, Dk
    Department 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.
  • Alza Corporation
    Senior Director, Process Engineering
    Alza Corporation Jan 2006 - Jun 2006
    Seattle, Washington, Us
    Department 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
  • Nektar Therapeutics Inc
    Director, Operations Engineering, Director Manufacturing Engineering
    Nektar Therapeutics Inc Sep 2001 - Jan 2006
    Department 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
  • Powderject Pharmaceuticals Plc
    Product Commercialization Manager / Senior Process Engineer
    Powderject Pharmaceuticals Plc Jul 1999 - Sep 2001
    As 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.)
  • Monsanto Inc.; Nsc Technologies Division
    Project Manager / Lead Project Engineer
    Monsanto Inc.; Nsc Technologies Division Apr 1998 - Jul 1999
    As 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).
  • Hauser Chemical Research
    Plant Engineer / Process Development Engineer
    Hauser Chemical Research May 1995 - Apr 1998
    As 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.
  • United States Navy, Submarine Force
    Engineering Watch Supervisor
    United States Navy, Submarine Force Jan 1986 - Jan 1992
    Responsible 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

  • University Of Colorado Boulder
    University Of Colorado Boulder
    Chemical Engineering
  • Westinghouse S3G Nuclear Engineering Program
    Westinghouse S3G Nuclear Engineering Program
    Nuclear Power Plant Engineering
  • Naval Nuclear Propulsion School
    Naval Nuclear Propulsion School
    Nuclear Power
  • Nuclear Power School - Naval Nuclear Power Training Command (Nnptc)
    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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