Kevin A Fukumoto

*** ******* ***** ***** *****: 408-***-****

Sparks Nevada, 89441 E-mail: adzslx@r.postjobfree.com

Summary of Qualifications

Over 25+ years of Management experience in the Medical Device/Pharma Manufacturing Industry with extensive experience in both Start-Up and full production environments. Comprehensive knowledge of CFR-210, 211, 820, cGMP, ISO9001 and ISO13485. Skilled in Lean Manufacturing and Continuous Improvement throughout Operations. Experience

Clasen Quality Chocolate, Spanish Springs, Nevada Sept 2021 to August 2023 Clasen Quality Chocolate is a major supplier of standard and customized formulations and value- added confectionary ingredients.

Retail Technician

• Perform pre and postproduction equipment and material checks.

• Operate food packaging equipment under GMP compliance.

• Breakdown equipment, sanitize and reassemble equipment.

• Manually package products into 40-to-50-pound boxes and stack onto pallets.

• Drive forklift to move pallets from production to warehouse. Breakthru Beverage, Sparks, Nevada Sept 2019 to October 2021 Breakthru Beverage is a leader in the distribution of fine wine, spirits, and beer. Merchandiser

• Stocking and rotating product to shelves, display building and Point of Sale material displays.

• Daily merchandising in customer accounts.

• Build strong rapport with key account and obtain feedback on merchandising activities. BioNex Solutions, San Jose, CA July 2016 to Sept 2017 BioNex Solutions manufactures Custom Laboratory Automation, Liquid Handling, and OEM Solutions

Production Manager

• Responsible for Pilot Production and Commercial build of custom OEM equipment.

• Coordinating commercial production launch including developing production documentation, working with R&D and Manufacturing Engineering to develop and implement process improvement, hiring and training technicians and implementing 6S.

• Prioritize production schedule based on resource availability, material availability and delivery schedules.

• Allocate resources for multiple product lines.

• Responsible for equipment calibration and preventative maintenance for entire facility.

• Responsible for facilities and maintenance.

Ariosa Diagnostics/Roche Sequencing Solutions, San Jose, CA October 2014 to July 2016 Ariosa Diagnostics manufactures Cell Free DNA diagnostics Sr. Manager Final Assembly and Packaging

• Responsible for developing and improving documentation for ISO13485 compliance in reagent manufacturing.

• Developing the infrastructure for the filling and final packaging team.

• Prioritize production schedule based on resource availability, material availability and delivery schedules. 2

• Review all batch production records for accuracy and completeness.

• Coordinate and ensure equipment calibrations and preventive maintenance are completed and current.

• Developing training program to ensure the reagent manufacturing team is trained on current processes and corporate compliance procedures.

• Support engineering with equipment validation and procedures.

• Dispensing and packaging final product.

Novartis Pharmaceuticals, San Carlos, CA February 2011 to October 2014 Novartis Pharmaceuticals, (San Carlos), manufactures inhalable antibiotics for healthcare. PharmOps Coordinator

• Responsible for 60+ Manufacturing Technicians over multi-shift, 24/7 operations.

• Champion team development and empowerment to maintain safety, quality, and production targets.

• Develop production plan ensuring resources and equipment are optimal.

• Coordinate monthly equipment calibration and preventative maintenance activities into production plan.

• Responsible for Kan Ban inventory management, (SAP Super User).

• Continue executing Manufacturing Manager responsibilities. Manufacturing Manager (3rd Shift)

• Recruit and develop/train Manufacturing Operations staff for commercial manufacturing.

• Support R&D, Process Development, Facility, and Validation Engineering Change Control.

• Analyze current manufacturing processes and implement Continuous Improvement/Lean Manufacturing processes.

• Responsible for Manufacturing Health, Safety, and Environment monthly auditing.

• Responsible for Manufacturing equipment calibration scheduling and OOT investigation/resolution.

• Responsible for analyzing and implementing cost reduction activities. Zosano Pharma, Fremont, CA December 2008 to February 2010 Zosano Pharma, (a Johnson & Johnson Internal Venture), manufactures a transdermal micro-projection delivery system.

Sr. Manufacturing Manager

• Recruit and develop/train Manufacturing Operations staff.

• Create and review manufacturing SOPs and Batch Records for various operations, equipment and processes.

• Support R&D, Process Development, Facility, and Validation Engineering Change Control.

• Manage Aseptic Manufacturing and Pilot Plant development and Production. Thermo Fisher Scientific, Fremont, CA April 2002 to Sept 2008 Thermo Fisher Scientific manufactures a variety of In-Vitro Diagnostic Medical Devices for health care.

Manufacturing Services Manager

• Manage Manufacturing Engineering, responsibilities include;

• Product/technology integration and transfer.

• Continuous Process Improvement, implementing 5s, and Lean Manufacturing.

• Recommend and Procure Automated Equipment included sourcing, financial ROI, appropriation requests, production floor layout, installation, and validation.

• RMA and Corrective and Preventative Action, (CAPA), investigation and resolution.

• Develop and procure production tooling.

• New product packaging design and associated manufacturing process and shipping validation.

3

• Manage Manufacturing Operations. Managed two manufacturing facilities, Filling, Lyophilization, and Packaging Operations, with 5 direct reports and a staff of 60.

• Lead multiple Cross Functional teams including; Continuous Improvement, Lean Manufacturing and 5S, ultimately reducing COGs and meeting on time delivery targets.

• Member of multiple Cross Functional teams including; New Product Introduction, OEM Product Realization, Customer Satisfaction, and Quality Systems Management.

• Developed and revised numerous Standard Operating Procedures for Planning, Manufacturing, and Quality Control.

• Developed, analyzed, and updated Manufacturing Capacity Planning, Routes, Cycle Time, Standard Cost and Work Order Variances.

• Authored numerous Work Instructions, Device History Records, Contract Manufacturing assembly instructions, product rework instructions, and equipment validation protocols.

• Investigate Customer Complaints and resolve through CAPA system.

• Create Manufacturing and Quality metrics, (KPIs).

• Prepare, monitor, and review Manufacturing Engineering and Manufacturing Budgets.

• Sourced, Procured, Audited, and Managed FDA Certified Contract Manufacturing resources. Iridex Corporation, Mountain View, CA April 2001 to March 2002 Iridex Corporation manufactures a variety of Medical Laser Systems, Optical Delivery Devices and Fiber Optic Disposable Delivery Devices for treatment of AMD and Aesthetic applications. Production Manager

• Manage Production of Laser Systems, Optical Delivery Devices, Disposable Fiber Optic Delivery Systems and Manufacturing Engineering.

• Member of the Design Control Team for the release of new products into production.

• Support production with tooling, equipment, and documentation updates via ECO process.

• Ensure Finished Goods Inventory is at an optimal level in conjunction with production forecast.

• Interface with Customer Service and Production Technicians to ensure customer returned, (RMA), equipment is serviced, investigated, and returned within 1 week from date of receipt.

• Designed new Production Floor to effectively utilize available space, create an efficient flow of materials, and managed Kan Ban inventory, (Lean Manufacturing).

• Capacity Planning and recruit candidates for open positions in production.

• Prepare and monitor annual budgets.

Eclipse Surgical Technologies Inc. Sunnyvale, CA April 1996 to March 2001 Eclipse Surgical Technologies Inc. manufactures medical lasers and fiber optic disposable devices for the treatment of Cardiovascular Disease via TMR/PTMR.

Operations Manager, Surgical Products

• Manage the Operations of Laser Systems Manufacturing and Disposable Fiber Optic Delivery System Production Team and Manufacturing Engineering.

• Member of multiple Cross-Functional Teams including Continuous Improvement, Customer Satisfaction.

• Member of Eclipse Compliance Team and Safety Committee.

• Prepare and monitor annual departmental budgets and maintain appropriate staffing levels per production requirements.

Laser Production Manager/Manufacturing Engineer

• Assist in the development, design, and transfer of the TMR Laser System to production.

• Developed Manufacturing Operations Documentation to support manufacturing, test, in-process and final inspection.

• Responsible for capacity planning and staffing for production requirements.

• Member of Compliance Management/Internal Auditing Team.

• Assist in ISO 9001 Auditing of suppliers and internal departments.

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