Supply Chain Project Manager

Christopher Kurtz

*** ****** ***, **** **** Bay CA, 94019

********@*****.***

Summary of Qualifications

Successful track record of over 28 years in global manufacturing, supply chain, CMC development, QA, QC, capital projects engineering, and program management for both drugs, biologics, and medical devices.

Completed development, gained FDA/EMA approval, and assisted in launching over 8 new products in the last 8 years.

Budgetary responsibility peaked at over $1.3 billion US per year

Staffing responsibility over multiple facilities peak at over 150 persons

Extensive experience developing, scaling up and commercializing drugs, biologics, peptides, medical devices, and combination products.

Expert people and project manager with extensive experience managing cross-functional teams spanning multiple countries and organizations.

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 over 6 major capital projects with the largest investment in excess of $400 MM.

Expert in supply base development and optimization, risk management, contracts administration and negotiations.

Deep experience and understanding of small molecule API, peptides, sterile dosage form, non-sterile dosage form, cell therapies, biologics, 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.

Recent major products launches include:

oZokinvy, Rezzayo, Biktarvy, Odefsey, Descovy, Vemlidy, Vosevi, Epclusa etc.

Employment History

Eiger Biopharmaceuticals Inc

Head of Technical Operations (CTO) – April 2022 – Present

Responsible for CMC development, analytical development, QC, QA, clinical and commercial manufacturing, global supply chain and program MGT for 5 assets: small molecule, peptide and biologics included. Prepared company for and executes the global launch of commercial products. Leads and directs organizational change initiatives in support of transition from R&D stage to commercial stage. Ensures company and supply base is prepared for global health authority inspections. Lead in prep and conduct review of CMC content IND, EUA, NDA/BLA submissions. Member of executive team reporting to the CEO.

Cidara Therapeutics Inc.

Head of Technical Operations (EVP) – Dec 2020 to Dec 2022

Responsible for CMC development, analytical development, QC, clinical and commercial manufacturing, and global supply chain for small molecule and novel biologics assets. Prepares company for the launch of commercial products. Leads and directs organizational change initiatives in support of transition from R&D stage to commercial stage. Ensures company and supply base is prepared for global health authority inspections. Assist in prep and conduct review of IND, NDA/BLA submissions.

Gilead Sciences Inc.

Head of Commercial API Manufacturing – Nov 2016 to Dec 2020

Managed global supply chain for all Gilead commercial API and chemical manufacturing, with peak spending of over $1.3 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. Assisted in implementing the company’s first global S&OP process. Implemented cost savings and avoidance programs that returned over $440 M to the business over 3.5 years. Led and developed a team of over 30 people with responsibility for MFG, supply chain, logistics, global tax and trade management. Developed supply chain cyber-security program, as well as formal supply chain risk management programs and health authority inspection readiness programs.

AbbVie Inc.

Vice President Drug Device Industrialization – Aug 2013 – June, 2016

Led drug device combination products Industrialization programs at $70- $100MM scale. Responsible for infusion pump development and industrialization, auto-injectors, topical applicators, and wearable auto-injectors. Created device and combination products development processes, implemented program management best practices, and improved and implemented upgraded design controls practices. Matrix management of very large teams, across AbbVie and at various distributed contract-manufacturing organizations. Led supplier selection, qualification, management and development for new products. Led contracts negotiation and dispute resolution. Led innovation teams in development of advanced care models incorporating drug, enabling IOT technologies, and services for new products. Helped conceive of and develop digital health solutions regulated as medical devices.

Independent Consultant/Contract Executive – May 2011 – August 2013

Supported numerous clients with CMC development and industrialization projects. Gained approval for AuviQ in partnership with Sanofi, the worlds first audio enabled autoinjector.

Alexza Pharmaceuticals

Vice President Global Supply Chain and Sustaining Engineering – June 2008 to May 2011

Line manager responsible for multiple departments including facilities, internal and external engineering, purchasing, EH&S, and supply chain management. Led contract and pricing negotiations for products and capital equipment. Managed forecasting and capacity planning for numerous suppliers worldwide. Established and managed an engineering team to provide technical services, manage tech transfer, support capital projects, and provide design engineering. Assisted in preparation and conducted critical review of US NDA for lead product. Conducted supply chain risk management analysis and developed a robust well qualified supply base for commercial launch. Prepared multiple facilities for PAI inspections and passed US pre-approval. Gained approval for Adasuve drug inhaler.

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Novo Nordisk Delivery Technologies;

Vice President of Research and Development – Jan 2008 – May 2008

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.

Director, Pharmaceutical Manufacturing and Development

Hayward CA. June 2006- Jan 2008

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, a division of Johnson and Johnson:

Mountain View CA. January 2006– June 2006

Senior Director, Process Engineering

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.

Nektar Therapeutics Inc: Director, Operations Engineering, Director Manufacturing Engineering

San Carlos CA. Sept 2001 – January 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 resource.

PowderJect Pharmaceuticals PLC: Product Commercialization Manager / Senior Process Engineer

Fremont CA. July 1999 – September 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.

Monsanto Inc, NSC Technologies Division: Project Manager / Lead Project Engineer

Mount Prospect, IL. April 1998-July 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

Boulder, CO. May 1995- April 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

San Diego, CA. January 1986- January 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.

Education

University of Colorado at Boulder: Bachelor of Science, Chemical Engineering

Westinghouse S3G Nuclear Engineering Program: Graduate

Naval Nuclear Propulsion School: Graduate

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