Matthew Young Email & Phone Number

Aliso Viejo, Ca, Us

▶️ Innovative Strategy and Operations: Developed organizational, manufacturing, supply chain, and product life cycle strategies to manage growth from $80M to $300M over a 5 year time frame. ✅ Lead operational transformation from medical device manufacturing to pharmaceutical manufacturing. Created an independent pharma manufacturing team to insource drug production and execute registration and stability batches. De-risk programs by developing novel technologies and internal expertise✅ Built a flexible manufacturing organization to scale capacity with internal and external sourcing mix strategies to launch 5 new products over a 5 year period. ▶️ Organizational and Process Improvement: Grew facilities by 280k ft2 and implement Lean principles to improve productivity, create a higher quality product, and increase compliance.✅ Developed an operational stage/gate framework and created a new functional Pilot Manufacturing group to lead new product / process implementation into manufacturing✅ Built a pilot organization to staff manufacturing personnel during late stage R&D to maintain an ongoing framework for due diligence activities and improve design for manufacturability (DFM) designs in R&D▶️ Transformational Leadership: Hired key leaders and collaborated with cross-functional leaders to ensure transformational growth while increasing compliance✅ Expanded key roles including hiring pharma internal and external manufacturing leaders, Facility Engineering & Program Management managers, a Supply Chain Director, and MSAT Engineering Leader✅ Collaborated with multiple cross-functional teams to implement new programs, strategies, and processes to address risks, increase productivity, and improve efficiency✅ Employed Facility & Tech Services teams to increase facility and infrastructure capacity in advance of realized sales growth and expanded R&D pipeline▶️ Board Member - Glaukos Charitable Foundation

Irvine, Ca, Us

▶️Innovative Strategy and Operations: Supported scale up of new products and responsible for technology integration of facility, systems, utilities, equipment, validation, calibration, maintenance, and continuity of manufacturing processes.✅ Initiated a functional review and gap analysis of the manufacturing team to identify areas of vulnerability and developed guiding principles for the organization including:⏩ Reducing errors by reducing reliance on manual process⏩ Decreasing compliance risk by improving data integrity⏩ Implementing regular capacity reviews▶️Organizational and Process Improvement: Identified process and system gaps and implemented redesigns and process improvements for manufacturing controls and systems.✅ Reviewed manufacturing control systems to industry standards and developed a gap analysis to implement an automated SCADA network to improve manufacturing process controls and eliminate single points of failure✅ Reviewed historical data for accuracy and compliance; redesigned process and implemented the CMMS Maximo✅ Led capacity reviews in advance of product filing and approvals and scaled up equipment for new product SAPIEN™ valve devices from launch to $1B in sales▶️Transformational Leadership: Performed a skills gap assessment to identify gaps in software and controls and hired a Controls Engineer and Software Validation Engineers

Irvine, Ca, Us

Member of the Leadership Team directing New Product Introduction (NPI) activities for the Surgical Heart Valve & Transcatheter Heart Valve businesses. Leading a cross functional Engineering and Operations team of 15 Engineers & 75 Operators) in tissue valve and catheter development. Established a dedicated operations team to manage all R&D and Clinical builds and scale up through commercialization. Provided leadership to formalizing and establish S&OP processes and metrics for NPI Pilot performance. ▶️Utilized DFM, Lean, Six Sigma, and functional feedback mechanisms to improve designs and reduce time to market and establish a dedicated pilot operations team to manage all R&D and clinical builds ▶️Reviewed organization’s current state against expectations and hired a dedicated a Pilot Manager with a strong engineering skill set to lead newly created Pilot Operations team▶️Eliminated development bottleneck by moving the build process from serial workflow to parallel workflows

Abbott Park, Illinois, Us

• Budgetary Responsibility: Process Equipment $52MM (Depreciation base), Headcount $15 MM• Value Stream Map (VSM) Team Leader for Continuous Improvement - Oliver Wight Class A Certification. Developed VSM training program and roll out plan to the Temecula site. Provided training to 63 individuals across 4 Business Units resulting in $5.49 MM in savings and reduced 25.2 days of non-value added time. Additionally provided leadership to optimize new and existing operations through Kaizen events and Lean 6 Sigma programs to support Class A Certification.•Six Sigma Champion – Provided leadership and mentoring to two 6sigma candidates yearly resulting in $150M in savings•Led a manufacturing team of 12 exempt supervisors and 450 non-exempt labor operators to meet global demand for drug eluting and bare metal coronary stent systems•Cross-Functionally Collaborated with quality, finance & accounting, business systems, labeling, regulatory, HR, and R&D to ensure a proper alignment of goals and expectations•Implemented a successful business process improvement and employee retention program which engaged employees to provide a higher level of commitment with continuous training and education for future expansion•Integrated Business Management Oliver Wight Class A Certification to reach 98.5% on-time product delivery while reducing inventories by 20%•Developed the Continuous Improvement Value Stream Management training to train 63 people across nine businesses, three manufacturing sites, and four cross-functional teams resulting in $5.5M in savings and 25 days added•Redesigned Organizational Process by retooling from high-volume manufacturing plant to R&D prototype plant and added a second manufacturing site for business continuity and maintained a high level of team engagement while facilitating product moves to offshore sites

Abbott Park, Illinois, Us

Provide leadership and direction to an engineering support group of 7 engineers and 17 technicians responsible for the XIENCE™ V Everolimus Eluting Coronary Stent / PROMUS™ Stent Chassis System product launch objectives. Emphasis on maintaining full compliance with regulatory requirements, maintaining efficiency in the manufacturing process and quality of the product portfolio, and ensuring the execution of plans for capacity planning, productivity improvements, quality initiatives, CAPA and the retention/development of key talent.• Budgetary Responsibility: Process Equipment $34MM (Depreciation base), Headcount $1.75 MM, Annual Projects $2MM.

Philadelphia, Pa, Us

Operations Management / Decision Sciences

Irving, Tx, Us

Multi-faceted operations and engineering role supporting eleven plants around the world, directly interfacing with manufacturing teams in Mexico, Honduras, Slovakia and China, as well as product development, R&D and Marketing groups located in the Eastern US. Additionally, served as Project Manager for Infection Control Business, supporting four international manufacturing plants generating $230 million net sales. Heavily involved in developing consistent operations practices across all manufacturing facilities and managing product supply.• Budgetary Responsibility: Project Specific up to $2.5MM returning 20% ROI. Multiple projects per year.

Irving, Tx, Us

Managed a functional matrix team responsible for supporting the Surgical and Infection Control businesses. Evaluated potential capital projects for financial justification and technical feasibility across eleven facilities. Implemented appropriate process validation procedures and documentation to achieve operating efficiency while meeting FDA regulations. Additionally, provided technical leadership and support of product development and manufacturing capability projects for Class I, II and III devices while maintaining customer service targets in a turbulent market (SARS / Avian Flu).

Irving, Tx, Us

Support the design, construction and start-up of an $80 million manufacturing facility and related product launch. Gained a solid foundation in designing new equipment and manufacturing processes, process scale-up, and leadership of multi-disciplinary teams to succeed in the product launch of Cottonelle Roll / Folded wipes. Budgetary Responsibility Process Equipment $20MM (Depreciation base), Headcount $250M

Irving, Tx, Us

Scientist managing a wet lab while working within a core R&D group managing physical property development and improvements of a Class II medical device (wound care fluid management and therapeutic dermal health applications). Developed interfacial surface treatments and applications to reduce pathogenic infections.

Mba, Business

Bs, Material Science & Engineering