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Supply Chain Medical Device

Douglassville, PA, 19518
October 11, 2018

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Trob **



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

Douglassville, PA 19518

+484-***-**** (m)

+610-***-**** (o)


Strategic Leader: 26 years of leadership combining vision, proven strategies, design and successful techniques for solutions implementations within the Global Pharmaceutical, Medical Device and Software Development industries. Directed multiple companies to unite on a single technology platform. Designed and implemented a Drug Discovery stage-gate governing IT program speeding decision points and NDA documentation. 24 years experience in designing and implementing strategic global initiatives in R&D, clinical and commercial supply chain management. BSBA Business, Green Belt Certified in Design Excellence SAP Supply Chain Management, BI

IT Supply Chain Strategy Design

Global Data Integration

Compliance & Product Development

Global RFID Supply Chain Solutions

Global GS1 / UDI design & Implementation

M&A Corporate Strategy Expertise

Process & Design Excellence




2007 - Present

Founder of this global information technology strategy and consulting services company specialized in the pharmaceutical and medical device industries. Company targets strategic M&A, improving technology that drives supply chain, R&D, sales, product development and collaboration solutions that improve efficiencies and compliance. Clients: Merck Drug Company, AstraZeneca, Bristol Myers-Squibb, DePuy Synthes, Tokio Marine, Takeda Pharmaceuticals, McNeil Consumer Healthcare, Pfizer, Integra Life Sciences, MedImmune, Arthrex, Thermo Fisher Scientific, Vertex, Innovative Supply Solutions Leadership, Vision, Innovation, Integration (select Trob 32 Programs) UDI Compliance Programs

• Program Manager for UDI project directed all GDSN, Vendor Procurement, GUDID compliance project for global medical device company Arthrex, Inc. 2014 - 2017

• Designed and led Global data integration and governance program for Trading Partners compliance (NHS, FDA, EU) Arthrex, Inc.

• Directed validation of hardware and software for global medical device company Integra Life Sciences. Lead vendor procurement, validation efforts for hardware, software and barcode verification. Label management compliance lead for selecting vendors and implementing solution 2013- 2014

• Directed the global UDI program for Thermo Fisher Scientific consisting of 11 Divisions, 28 locations covering 10 countries, and $1 billion dollars in product revenue. Led the GS1 Barcode Verification program. 2015 - 2017 Global Program Management

• As a key member of the Program Management Organization at Takeda Pharmaceutical 2008 - 2009 o Led a team in the design, upgrade and implementation of a specialty product commercial Chargeback and Rebates system for Takeda Pharmaceutical.

o Directed M&A integration of global SharePoint migrations to a single SP platform.

• Organize and author validation documentation to bring McNeil Consumer Healthcare MES systems out of Consent Decree. Includes scales, infrastructure, Work Instructions, SOP’s, and interfaces (OSI PI). 7/2008 – 12/2008

• Led a team of business and IT professionals that developed and implemented Global RFID GS1 UDI solution for leading medical device company DePuy Synthes. Implemented solution in the United States. 2009 - 2010 o Established RFID requirements and standards for deployment of systems throughout the company o Established a repeatable business and installation procedures for a rolling global deployment of RFID o Directed the first implementation of an RFID solution at global distribution center. Returned 8 FTE’s, improved efficiencies and automated invoicing saving $650k per year. (cont.) ROBERT AST +484-***-**** (m)

+610-***-**** (o)

• Engineered the design, development and implementation of custom SharePoint 2007 for the R&D Product Development governance at Bristol Myers-Squibb leveraging a .NET, Oracle MOSS 2007 solution. Revolutionized the document management process for discovery at BMS. Automated R&D workflow, solution facilitated and resolved questions, conflicts and issues, and accelerated drug discovery Stage Gate review. Validate UAT test scripts and results. Project received CIO award for innovation. 7/2007 – 7/2008

• Developed, prototyped & piloted a SharePoint R&D collaboration portal solution for leading cancer drug product at Merck Drug Company. Portal facilitated collaboration between product teams. 3/2007 – 8/2007

• With Director and CIO of AstraZeneca, establish metrics for measuring performance to establish consistent project delivery, reporting standards and improve quality in the Solutions Delivery LCM division (PMO). Automated metrics reports interfacing with Project Management Software (Clarity) saving .25 FTE’s per week of senior management effort.

o Directed Sales Force Automation program for designing and deploying to 6000+ Pharmaceutical Sales Specialists. Managed business and consulting resources (Accenture, Cognizant, AZ) o Implemented SAS and Proscape software for Closed Loop Marketing.

• Direct Microsoft SPOL externalization program for third party collaboration at MedImmune (R&D for AZ) DELOITTE CONSULTING, PHILADELPHIA, PA


2010 - 2012

Recruited by company to design IT strategy for our life sciences clients. Deloitte is a premier consulting firm ranked

#1 in Healthcare and Consulting services. Direct systems integrations for major pharmaceuticals, Medical device companies, mergers and improve supply chain efficiencies. Successes

• Design IT strategy for global pharmaceutical manufacturing division to achieve Lean supply chain objectives

• Design implementation of 2d vaccine barcode system for the Center of Disease Control.

• Develop and launch new Medical Device supply chain service offering for Serialization, GS1 Standards and Strategies, Supply Chain Emerging Technologies, UDI, Packaging and Labeling and RFID. FIRST CONSULTING GROUP, Wayne, PA



Recruited by company to rebuild a broken client relationship. FCG is a specialized consulting company with multiple verticals in the healthcare and pharmaceutical industries. FCG offers an industry wide accepted Documentum layer solution

Relationships, Delivery

• Re-built the company reputation by ensuring successful on-time, under budget execution of multiple key document management solution projects.

• Led the vision, design and Proof-of-Concept efforts for integration of a highly customized document management solution with a corporate wide SAP initiative at premier global pharmaceutical company.

• Improved corporate program profitability from negative (12%) to a profitability of 89% BUSINESS EDGE, EAST BRUNSWICK, NJ



A specialized consulting company with program management expertise in the IT industry. Leading Integrations

• Led the solution design and implementation of Business Intelligence software that managed contracts by interfacing to verticals of the commercial drug supply chain. Write and manage results of software development Unit Testing prior to final UA testing and deployment. BI integration testing.

• Spearheaded the replacement of antiquated and manual applications with an automated global solution.

• SME and directed all needs assessment workshops, solution design and management of UA testing and documentation.

• SAP interface consultation for global SAP effort. Relationship management between Merck and multiple software partners.

ROBERT AST +484-***-**** (m)

+610-***-**** (o)



J&J is an industry leader, global pharmaceutical and healthcare company with revenues $51B USD and 116K employees worldwide. Recruited by company to rebuild global relationships between IT and Business units. Innovation, Global Program Management, Results

• Streamlined a manual protocol reporting process that generated metrics for management. Innovated new six sigma reporting tool, automating the reporting process improving efficiency saving over $600K annually.

• Accountable for all Global Clinical Supply Chain software including custom and off-the shelf. Full Validation accountability utilizing V model for business requirements, design, UAT script writing, testing, traceability sign-off and SDLC. Validation training certified annually. Includes LIMS, custom Packaging solutions globally.

• Produced new company standard in Design Excellence evaluation process to qualify and quantify vendors / products quantifying selection.

• Led multi company SAP Clinical Supply Chain program from qualification through installation utilizing IBM ASAP methodology. Modules WM, PP PI, SD EH&S, ABAP coding $26mm Budget. EMAX SOLUTIONS PARTNERS, LTD, NEWTOWN SQUARE, PA



EMAX is a consulting solutions company providing specialized R&D Supply Chain solutions in the Pharmaceutical industry

Integrations, Corporate Direction

• Developed and successfully implemented multi-million dollar custom global R&D Supply Chain solutions for large pharmaceuticals. Designed solution for interfacing to automated plate storage systems (Kardex, TAP) solublization robotics (Sagian) and lab equipment (Mettler) to accelerate drug discovery, removing manual processes and minimizing potential for error.

• Managed the SDLC of a corporate wide effort to produce a company-wide standard off-the-shelf product solution. Final product offering generated 46% of company’s revenue and reduced support costs by over 65% within 6 months of implementation.

• Full software validation accountability for designing and authoring UAT of custom designed client solutions, and corporate standard product offering.


Robert Ast, President

Trob 32 Incorporated

SME Expertise: Strategic Information Management, Knowledge Management, Team Collaboration, Business Intelligence, Global Program Management, Validation (CFR, SOX, eSignature), Supply Chain (R&D, Clinical, Commercial), Information Technology (ALIMS, Activity Base, Documentum, SAP, SP07), R&D Solutions, Process Engineering & Implementations, Robotics Interface design, Design Excellence. SharePoint Online, RFID, UDI Compliance. Executive Summary: With over 26 years of strategic Program and Information Management for large Pharmaceutical, Medical Device and Software Development, Robert has extensive experience in identifying and leading strategic Information Technology design and implementations. This expertise encompasses extensive global program management, business process design, development and directing multiple Program Management Offices, Enterprise Knowledge Management Council and process improvement. Robert has helped establish and advance the commercial, clinical supply and R&D supply chains for top10 pharmaceutical companies. His software vision, design and global deployments have been implemented at Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Merck Drug Company, Hoffman-LaRoche, Bristol Myers-Squibb, AstraZeneca and Synthes. Individual programs Bob has led range in size and scope from 200 to 65,000 users and financial accountability ranging from $2mm to $26 mm . Key to his success, Bob’s background in global program management comes from his successful creation of Project Management and Knowledge Management Program Offices in the Pharmaceutical Information Technology and Consulting industries. His project management principles and metrics methodology is based on his Green Belt expertise in Design Excellence. “Delivering quality solutions requires sound information, clearly defined objectives and the driven desire to exceed expectations.” Ast said. “Passion to surpass expectations fuels success and innovation, essentials in this data driven industry.” With residence in Pennsylvania, Bob is also active in the local community; including playing Santa for the Relay for Life organization. He is married to his wife Patricia for 22 years. Trish is a schoolteacher and possesses a BSBA in Marketing. They have two (2) children. Titles Held: President, Director Program Management, Director Project Management Office, Global Program Manager, SME Consultant, Senior Engineer

Industry Experience:

Bob has held positions and consulted in Pharmaceutical giants like Johnson & Johnson, Merck Drug Company, Bristol Myers-Squibb, AstraZeneca,Hoffman La-Roche and Wyeth. He has also held Senior Management positions in the telecommunications industry leaders MCI and British Telecom, L.L.C. Medical Device companies such as Thermo Fisher and DePuy Synthes.

Education: B.S. Business Administration Western New England College Springfield, MA Green Belt Design Excellence

Memberships: Amity AC Board of Trustee, DIA Presenter Green Belt Design Excellence Certifications: Green Belt, Design Excellence

Hobbies: Woodworking, gardening, exercise including bicycling, running, weight lifting, soccer, automotive and any activities involving his children

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