Management Project

Matthew Gritz

**** ******** ******

Oak Park, CA 91377

760-***-**** m ***********@*******.***

Career Summary

Over 13+ years of leadership experience driving quality, profitability and efficiency in biopharmaceutical manufacturing. Able to combine strong technical innovative proficiency with interpersonal skills to bring diverse groups together to accomplish common goals. EXPERIENCE:

Baxter, Inc., Los Angeles, CA 2014 Current

Manager I, Quality

Responsible for developing and implementing the site Microbial Contamination Control Master Plan for Environmental and In Process Bioburden to reduce potential risk to product operations. This Includes troubleshooting and solving bioburden issues within the facility by applying critical problem solving tools (e.g. Lean Six Sigma, DMAIC) to improve observed negative trends through implementation of continuous improvement initiatives.

● During March 2015 (triennial audit) FDA Lead Auditor, Mihaly S. Ligmond, recognized the Los Angeles Manufacturing Facility (LAMF) for our bioburden reduction intiatives and process improvements such as In Process Bioburden, Critical System failures, and Environmental Monitoring excursions as compared to previous audit (2012).

● 63% reduction in Building 5 Teardown and Fractionation Department In process bioburden excursion rate resulting in $348,000 investigational department savings. o B5 Teardown Bottles (Bacteria recovery) sample excursion rate was reduced from 75% January to 0% May. B5 Cuno Fr 2+3 (Yeast recovery) sample excursion rate was reduced from 7.5% January to 0% March. Then sustained at 0% until June (annual plant shutdown).

● Q2 2015 was the best quarter ever recorded in B5 Teardown and Fractionation Department history

● B5 Cell 1 Bag Teardown set department and company record with 267 Bag Teardowns without an action Bacteria OOL (since March 14, 2015)

● B5 Cell 1 Bag Teardown set department and company record for the most zero (0) CFU recoveries

@ CRP sample (sub pool 1 and sub pool 2) with 192 out of 230 opportunities From March 14, 2015 until shutdown, 83.48% we had zero recovery

● B5 Cell 1 Bag Teardown set department and company record for lowest excursion rate 3.31% @ CRP sample

● 100% elimination of action OOL for Yeast reduction @ Cuno Fr 2+3 Q2 2015 was the best recorded quarterly excursion rate 0% @ Cuno Fr 2+3 (compared to the previous 5 quarters)

● 57% reduction in Building 1 Teardown and Fractionation Department In process bioburden excursion rate resulting in $144,000 investigational department savings

● Q1 2014 Fractionation Department and Company record for lowest excursion rate @ CPP 0.8% Q2 2015 Fractionation Department second best quarter for lowest excursion rate @ CPP 0.85%

● Q1 2014 Fractionation Department and Company record for lowest excursion rate @ Fr23 Extract 1.8% Q1 2015 Fractionation Department and Company tied record for lowest excursion rate @ Fr23 Extract 1.8%

● 41% reduction in Building 1 APD Department In process bioburden excursion rate resulting in

$84,000 investigational department savings

Baxter, Inc., Los Angeles, CA 2012 2014

Compliance Excellence Leader II, Business Excellence Responsible for creating and leading cross functional teams to ensure that compliance gaps are appropriately addressed by using investigation/DMAIC/lean tools to develop robust root cause analysis

● Participated with other managers in setting the project strategy, schedule, and resources to ensure root cause is eliminated within stated goals and timelines.

● Lead rapid Kaizen events for the purposes of business process development, waste elimination and cycle time reduction.

● Participated with other managers in setting projects’ strategies, project plans, resource alignment, and financial analysis. Educated and prepared site for regulatory inspections.

● Identified turn key best practices from national and international sites and implemented locally.

● Oversaw and coordinated the operational aspects of ongoing compliance projects, serving as a liaison between project management and planning, project teams, and line management.

● Successfully facilitated problem solving events consisting of Engineering, Maintenance, Manufacturing and Quality for the following:

o B1 Fractionation Mold 1 and Mold 2 In Process Bioburden (IPBB) trend Fr II+III extract o ICAR/ Lessines PPT G IPBB trend

o B1 Fractionation IPBB Fr II+III extract

o B5 RO Coliform Filter Press 2

o B1 Filling Complex Unfavorable trend for Mold Environmental and Personal Monitoring Excursions

● In response to clean room contamination issues, created and implemented preventative maintenance cleaning processes based on review of environmental monitoring and in process bioburden excursions.

● Identified system issues with RO water process and an engineering design flaw in the process piping and valve sequence timer. Implemented site wide improvements in operating procedures.

● Reduced overflow in the air cooled centrifuge process which resulted in 100% eradication of yeast contaminations

● Led cross functional team that implemented standardized and specialized cleaning processes and re design of the cooling system’s process piping and demister. In less than six months, the team drafted/approved the project proposal, received finance approval, designed prototype and completed final report for study protocol.

● Submitted the Fractionation Department’s first DDFP (Developing Defect Free Processing) visual aid that was implemented as part of the department’s training qualification. Achieved a 50% reduction in discrepancies due to incorrect set up of the equipment. Genentech, Inc., San Diego, CA 2005 2012

Lead Manufacturing Bioprocess, Technical Transfer of New Products Responsible for GMP compliance and record keeping, staffing assignments and project planning, training and education, equipment validation / maintenance, inventory management, scheduling, production of Rituxan, Avastin and Actemra that generate $5.1 Billion of revenue.

● Analyzed historical database to identify inventory with expiration dates that could be extended. This reduction of raw material expenses results in annual cost savings of $700,000.

● Used Lean/DMAIC to eliminate excess drug product wastage and to increase use of automation with ongoing reduction of expenses by $2M. Project was awarded Process Improvement Award.

● Initiated use of disposable containers to eliminate three major steps in product preparation that reduced staff by 30% and increased efficiency by 400%. First site of entire network to implement disposable containers.

● Converted inventory system to SAP, a business management software product, to improve inventory management, scheduling, workflows and data integration. Biogenidec Inc., San Diego, CA 2002 2005

Associate III, Biopharmaceutical Sciences, Cell Culture Responsible for cell fermentation for the production of monoclonal antibodies for use in clinical trials. Designed and implemented training programs. Used analytical / quantitative skills to collect/ record data, track process trends and provide timely, accurate reports to management

● Successful management of complex projects including the start up and validation of a new $408 million biopharmaceutical fermentation facility and a $60 million Clinical fermentation facility on time and within resource constraints.

● Developed and wrote the Standard Operating Procedures for a new production facility from analysis and interpretation of functional system specifications.

● Collaborated with multiple departments to perform operational qualifications of manufacturing control software, bioreactors, and laboratory equipment.

EDUCATION:

University of California at Santa Barbara: Bachelor’s degree: Biological Sciences Additional Course Work:

Introduction to Lean For

Manufacturing

Lean and Six Sigma Trained

(Baxter)

DMAIC for Projects and

Planning

Total Productive: Autonomous

Maintenance Training

Project Management Basics Root Cause Analysis (RCA) Process

Total Productive Maintenance

Specialist

Corrective and Preventive

Action (CAPA) Process

Introduction to 5S

Kepner Tregoe Problem Solving &

Decision Making

Quality Control Discrepancy

Process

Discrepancy Management

Process

Crucial Conversations Building and Leading Teams Presentation Skills Building a Strong Reputation by

Creating a Personal Brand

Building Bridges through

Networking

Working With Challenging

People

Train the Trainer: Essentials and Skills

Workshop

Understanding Inclusion Making Meetings Work

SAP Training

PSA Material Movement, Demand to Supply Process Inventory Control Cycle Counting Manufacturing Reporting Analysis and Troubleshooting SKILLS:

● Innovative, results driven Team Leader

● Lean / DMAIC

● Excellent interpersonal and communications skills

● Proficient in computers including Delta V, Microsoft Word, Excel, and Power Point

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