MARYDAWN MEEDER

Professional Engineer (PE) • MBA • PMP • BS Mechanical Engineering • MS Software Engineering

Information Technology Leader • Project Management

Healthcare Systems • Lab Information Systems • Life Sciences • Genomics • Pharma • Aerospace

Six Sigma / TQM ● Change Management ● Restructuring & Turnarounds ● IT Infrastructure New Projects ● M&A Integration

PROFILE: IT leader with 30 years of progressively challenging experience – from startups to the Fortune 500 – especially healthcare, pharma, genomics, and consulting. Extensive experience in new lab and building IT infrastructure and capturing business requirements, Laboratory Information System lifecycle and launch of new products in Oncology, Genetics and Genomics

2016-2017: Exceeded Project Timeline for New Genomics Lab for Cornell and New York Presbyterian

PMI Certified; Fully versed in Project Management Book of Knowledge versions 5 and 6

Technical Skills: Laboratory Information Management Systems software development life cycle expertise(Agile, Waterfall, Traditional), report development, testing, and training; (Specific knowledge of Lab Vantage, Labware, Orchard Software, CSols, COTS, in-house) Expertise in Development of Document Management Systems to meet Regulatory requirements(Specific knowledge of SharePoint, SAP; elevate modeling and data extraction for use in genomic reporting ; system integration skills in connection of LIMS to Lab automation, sequencers, and accessioning and reporting systems; Large Scale system operations for high volume laboratories, using Oracle platforms; Collaboration and workflow automation

Functional Skills: Supervision and direction of employees; All aspects of recruiting, hiring and Staffing for Laboratory Information Technology, Lab Systems, and Lab Operations; Development of Standard Operating Procedures to Compliance Requirements; Training and tracking of training for Quality Management System, Process Development, Process Improvement, Business Process Engineering

EDUCATION, P.E. LICENSE, AND CERTIFICATIONS

MS Software Engineering, PENN STATE UNIVERSITY, 1990

MBA, Finance, VILLANOVA UNIVERSITY, 1989

BS, Mechanical Engineering, CLARKSON UNIVERSITY, 1983

Professional Engineer, Licensed New York State, 1983

Agile, Project Management Certification, Software Development Life Cycle, 2012

Program Manager Professional (PMP), PMI Certified, Quest Diagnostics, 2006

Athenex Pharmaceuticals, Dunkirk, NY,

Senior Manager, Operational Technology and Start-up, Dunkirk, NY June 2021-January 2022

Managed all aspects of Operational Technology for Pharma plant – infrastructure, Automation selection; Worked with Construction Company on Telecomm, Building Management System implementation and Process Control System implementation

Project: Startup of New pharma plant, with new production operation of oncology products, including automation, robotics, quality management system, process control system and building management system

Specific Deliveries and Responsibilities: Selection and development of Rockwell Automation and associated service and support; Process Control development for Environmental Systems; LIMS implementation (from business requirements, functional requirements, IQ-OQ-PQ Quality deliverables, through User Acceptance testing); Staffing of New Lab Personnel; Training

Information Technology Consulting, ERIE Insurance

System Analyst, SERVICENOW June 2019-Sep 2020

Managed all aspects of new enhancements to the ServiceNow ERP system, focused on internal customer requirements

Specific Deliveries and Responsibilities: Delivered 3 new Releases to the IT Organization

RMK Consulting, Cornell & New York Presbyterian Hospital,

Project Manager, New Lab Construction and Start-up, NYC, NY August 2015- June 2019(Contract)

Managed all aspects of IT – infrastructure, ISP selection; Worked with NYC Turner Construction Company on Telecomm Prints for installation of lab infrastructure data center and call center; managed Lab Info Management System and software development

Project: Startup of new genomics Lab, with new test menu of 16 genomics product offerings, including Next Generation Sequencing analysis of cancer specimens for genomic alterations and biomarkers

Specific Deliveries and Responsibilities: Selection and development of IT infrastructure; LIMS implementation (from business requirements, functional requirements, IQ-OQ-PQ Quality deliverables, through User Acceptance testing); Staffing of New Lab Personnel; Training

Cybersonics, Erie, PA Sep 2014-August 2015

Medical Device Manufacturer; ISO 13485, FDA Compliant manufacturing of medical devices

Director of Information Systems; Acting Director Quality

Evaluation and implementation of electronic Quality Management System

Project: Selection and Launch of Quality Management System

Specific Deliveries and Responsibilities: Evaluation of Off the Shelf and Custom QMS for the Medical Device industry; Make versus buy financial evaluation; Selection of QMS; Implementation of QMS, including all vendor communications, selection of new staff, training

DIRECT ALLERGY, Erie, PA May 2014–Sep 2014 (Contract)

Startup med-services firm • Provides physicians with customized immunotherapy treatments for on-site allergy and asthma testing

Director of Corporate Operations & Acting Chief Financial Officer (CFO)

Set up “big company” systems for a fledgling startup that struggled to meet its sales forecast. Took charge of the CFO role – leveraged MBA in finance – and ran finance as well as operations.

CMI ENERGY, Erie, PA and Seraing, Belgium May 2012–July 2013

Mechanical engineering group – HQ Belgium – produces machinery for steel plants, industrial heat recovery equipment, and boilers

Senior Project Manager for Large Capital Projects

Led projects in Russia and Bangladesh. Relocated to CMI’s HQ in Belgium for 4 months.

●Typical Challenge: Emergency repair for boiler baffles – part of a Heat Recovery Steam Generator (HRSG) – located 90 miles north of Moscow. A specially qualified team of welders was needed but hiring qualified personnel – either US or local – was problematic due to legal and tax regulations. Repair window was exactly 4 days, during planned maintenance for the main plant.

●Solution: Contacted former mechanical-engineering colleagues at various companies – especially in GE supply chain – and assembled a team of qualified engineers and welders from Ireland.

●PMBOK Version 6; Reported to Author of Version 6; Tested and Passed Certification against PMBOK version 6

Flew the team into Moscow, transported them to the Power Plant site, and relayed repair instructions from CMI’s engineering team in Erie, PA.

Hired a translator: Site supervisor spoke only Russian and final inspection was done in Russian. Transported construction materials to the job site – exactly when needed for repairs.

Completed the job on time and within budget.

FOUNDATION MEDICINE, Cambridge MA Feb 2011–May 2012

Startup firm, privately held • Provides patients with genomic profiles that predict probability – and best remedy – of certain cancers

Vice President, Information Technology

Hired to run a selection process and lead implementation of a Lab Information Management System (LIMS). Hired by FM based on experience with similar systems at Quest and Nongenomic. As a startup, FM urgently needed LIMS to scale up to accommodate explosive growth.

●CHALLENGE: Existing LIM systems were designed to track samples through chemical-testing process. FM approach is based on mathematical algorithms and software analysis of person’s genetic code.

●Foundation Medicine had to creatively adapt an existing “off the shelf” system to track samples.

●ACTIONS: Set up a vendor-selection process that resulted in a contract with Thermo Fisher. Deployed FM’s first LIMS into daily production. Configured the system for FM’s state-of-art algorithmic approach to lab testing – a unique application of the Thermo Fisher’s LIMS.RESULTS: Delivered a fully operational LIMS – from original concept through UAT (user acceptance testing) – and achieved full regulatory compliance with CAP, CLIA, and 21 CFR Part 11.

NEOGENOMICS (NASDAQ NEO), Ft. Myers, FL Jul 2010–Aug 2011

Operates a 6-site network of highly complex, CLIA-certified clinical labs that specialize in diagnostic testing via cancer genetics

Director of Information Technology

Stepped out of my traditional IT role. Applied MBA and Six Sigma Green belt skills. Led a process improvement team that significantly cut turnaround time for Cytology and Cancer Diagnostics.

●SCOPE: purchased, customized, and implemented new LIMS in record time. Managed all aspects of IT including infrastructure, telecom, custom software dev, vendor management, and project management.

●TOP RESULTS: Cut processing-and-delivery time for cancer tests from 24 days to 4 days.

EXIQON (NASDAQ: EXQ), San Juan Capistrano, CA Sept 2009–July 2010

Hospital Services – global supplier of products to biotech and pharma for microRNA R&D (genetics-based cancer research)

IT Director for Regional HQ

Managed all aspects of IT – data and call centers, infrastructure, call center, LIMS & software dev.

●MAJOR PROJECT – BUSINESS ANALYSIS: Worked closely with ops to analyze costs of testing, which identified the specific costs of California labor, equipment, and materials for the Lab's primary test.

Calculated true costs of Exiqon’s primary cancer-diagnostics test, and discovered the costs exceeded the govt’s reimbursement.

Presented results to EXIQON executive management in Europe that the, resulting in business decision to close CA location. Led IT shutdown, including preservation & security of patient data.

QUEST (NYSE: DGX), San Juan Capistrano, CA Jan 2006–Sept 2009

World’s leading provider of diagnostic services • $7.1 billion revenue and 41,000 employees • HQ in Madison, NJ

IT Director for Regional HQ – Hospital Services

Hired to lead the transformation to new technology. Recruited into quest based on personal reputation as a change agent with IT expertise and pharmaceutical background.

●SCOPE: Reported to SVP Diagnostic Systems and Services: Managed 10 direct and 300 indirect reports and all IT: operational, financial, HR, tech strategy, software development life cycle, and infrastructure. Managed 3 budgets: $15M operating / $9.5M capital / $2.3M projects.

●BACKGROUND: Quest’s systems were so outdated that vendors stopped supporting. Completed the overhaul under budget, on schedule, and with no interruption to business operations.

●ACTIONS & RESULTS: Most significant goal achievement was change management, because the daily work of every lab employee was dramatically changed by introductions of new systems.

M&A Integration: Devised and executed migration strategies for 4 large-scale, multi-location acquisitions. Met all cost-savings targets, including $22M merger with largest clinical laboratory. Standardized 1,200-test code database across 33 regional labs.

Transformed and reorganized the IT department as part of enterprise-wide restructuring. Cut an entire layer of management and identified areas for outsourcing. Negotiations with foreign & domestic government for call and data centers, which saved 40% over 2 years. Deployed software development platform that allowed code re-use, which cut development time and OPEX by 31%.

Cut development time more than 50% (from 9 months to 16 weeks) by introducing project management discipline, Six Sigma, and structured SDLC methodology (PEP3).

Ensured regulatory compliance with ISO, Sarbanes-Oxley 21 CFR Part II, and CLIA. Fixed numerous audit findings, which led to satisfactory results for 6 major audits (no findings in 2007).

SANOFI / GENZYME GENETICS, Santa Fe, NM Jan 2002–Jan 2006

Genzyme: biotech company based in Cambridge, MA • Acquired by Sanofi in 2011

Senior Director, Information Technology

Recruited by previous boss (Smith-Kline) to overhaul a stagnant IT department that failed to scale up and meet standards during high growth that was driven by breakthroughs in prenatal testing.

●SCOPE: Reported to SVP/COO, controlled budgets ($5.5M ops / $7M capital) and directed IT for 5 labs in US & Japan: software development, help desk, call management, network & database admin, vendor relations, software license agreements, technology strategic planning, and genetics-testing operations.

●TURNAROUND: Transformed IT into a strategic business partner by upgrading 10-year-old technologies and retooling department for 100X growth. Led numerous, large-scale projects on time and on budget.

●INFRASTRUCTURE AND SYSTEMS: Led design and construction of server room & data center with no interruption to operations. Created emergency IT plan, with full server redundancy /WAN backup for 24-hour operations across 4 service providers. Delivered major systems for sales management, online ordering, lab delivery, specimen tracking, and patient scheduling.

●PROCESS IMPROVEMENT, EFFICIENCY, AND COST SAVINGS: Saved $12M y-o-y by reducing average call time 30%. Increased availability from 90% to 99.9% with 30% cost savings. Renegotiated contracts for data/telephony. Cut overhead $250K by renegotiating contracts and reducing headcount.

ADDITIONAL EXPERIENCE (MAY 1983–JAN 2002) GE MANUFACTURING PROGRAM HEALTHCARE IT

TACIT, Palo Alto, CA (Jan 2001–Jan 2002): DIRECTOR OF CONSULTING SERVICES AND PROJECT DIRECTOR: Led deployment of “Knowledge Mail” software for clients in life sciences, pharmaceutical, and aerospace. Completed major projects for Northrop Grumman, Lockheed Martin, and Sanofi-Aventis – cut research time for Sanofi-Aventis’ Drug Innovation and Approval Org 7.8 person-months.

EMAX SOLUTIONS / SCIQUEST, Newtown Square, PA (Jan 1999–Dec 2001): CONSULTANT AND PROGRAM DIRECTOR for application development and consulting firm: Managed $2.5M project budget and led team of 5 direct & 15 indirect reports. Ran project management & planning, process reengineering, and client development.

SMITHKLINE BEECHAM, Collegeville, PA (May 1991–Jan 1999): Advanced through four roles: DECISION SUPPORT MANAGER, MANAGER OF OPERATIONS, MANAGER OF PROCESS ENGINEERING, AND MANAGER OF PROCESS IMPROVEMENT.

●Automated processes saved millions ($USD) and supported international laboratory ops. Kept moving forward throughout facility moves, promotions, reorganizations, and process-improvement initiatives.

GENERAL ELECTRIC, Valley Forge, PA (May 1983–May 1991):

●Began career in GE’s Manufacturing Management Program. Completed intensive training in Management, Leadership, Project Management, and Proposal Development.

●Quality Manager, Aerospace

●Advanced through roles as Program Manager, Supervisor of Industrial Engineering, and Manager of QA.

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