Senior Supply Chain Management Leader

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NAGY FAWZY

*******@*****.*** l 732-***-**** l Piscataway, NJ 08854 l www.linkedin.com/in/nagyfawzy SENIOR SUPPLY CHAIN MANAGEMENT LEADER

Achieve Strategic Business Goals Optimize Performance, Improve Reliability Deliver Cost Savings

• Accomplished Leader: Comprehensive experience in the pharmaceutical industry developing and executing complex portfolio of programs in R&D and Supply Chain operations and track record of achievements to deliver business results and strategic goals in a lean and agile way. Build lucrative partnerships and influence innovative business strategies to ensure resilient and reliable supply for small and large molecules production in global multi-disciplinary environments.

• E2E Operations: Lead high-performance cross-functional matrix teams through New Product Introduction and Life- Cycle Management applying sound scientific expertise in drug development, deep knowledge of manufacturing processes, process improvement, project management, and business skills in sourcing and negotiation to deliver product goals and support launch.

• Specialized Expertise: Develop business cases, aligning with stakeholders, solving problems, and shaping sourcing decisions. Demonstrated success leading through organizational change and navigating through ambiguous environments to consistently meet commitments.

SKILLS & EXPERTISE

Strong Leadership Project Management Dynamic Communication Adaptability Critical Thinking Influencing Skills Strategic Sourcing & Procurement Supplier Relationship Management Alliance Management Risk Management Quality Oversight & Supplier Qualification Multi-Tasking and Prioritization Active Listening PROFESSIONAL EXPERIENCE

JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON 2003 - Present Senior Manager, Procurement - New Product Development (2018 – Present) Janssen Supply Chain

Manage Procurement activities to support New Products Launch and delivery of business plans. Drive supply chain resilience, reliability, and agility in direct materials supply supporting Janssen’s $25B Biologics Platform including growing Advanced Therapy pipeline. Define and implement category strategies. Deliver targets for financial performance. Manage communications as Primary Point of Contact (POC) for value stream teams, categories, and enterprise value chain risk management and present findings to senior executives.

• Reduced COGS and drove $3M in cost saving that delivered value for a combined programs revenue of $300M+ annually by qualifying a strategic source for a critical material.

• Influenced strategy alignment by partnering with business stakeholders driving strategic plans.

• Identified and implemented mitigation/business continuation plans to de-risk materials supply, generate cost value, prevent production disruption, and ensure launch readiness and sustainable supply of new products.

• Supported global cross-functional Diligence Team defining critical questions, tracking activities, and working with Business Development to establish license/contractual agreements.

• Shaped external manufacturing sourcing decisions ensuring sustainable Right-First-Time supplier selection.

• Defined unmet needs and collaborated with internal/external partners driving innovation on new oligonucleotide product.

• Negotiated supply and services contracts that enabled programs development and clinical progress. Manager, External Supply Quality (2017 – 2018)

Janssen Supply Chain

Oversaw Quality Assurance Management of clinical production processes at 2 external manufacturers including technology transfer and pack & label. Drove manufacturing process optimizations. Led functional discussion in Top-to-Top Governance meetings with external partners. Developed and executed quality systems to ensure compliance adherence. Page 2

• Negotiated Quality Agreements with external partners to enable process and technology transfer.

• Managed resolution of deviations, CAPA investigation, process issues and complaints at external manufacturers to enable production campaigns progress and eliminate wasting costs.

• Supervised partners’ performance to ensure implementation of Enterprise Strategy, adherence to established Key Performance Indicators (KPIs) and reduce overall risk.

• Conducted customary audits to qualify external clinical manufacturers. Value Chain Leader, Value Stream Management (2016 – 2017) Janssen Supply Chain

Drove Launch Readiness activities and secured resources needed for flawless and cost-efficient global commercial launch, and Technical Transfers of new products and processes from R&D to commercial sites both internally and externally. Ensured supply sustainability of a portfolio of new products including post-launch supply continuity.

• Led New Product Introduction activities for three strategic projects that enabled timely completion of deliverables and key product launch.

• Managed supply chain activities to ensure successful tech transfer and to support timely DS and DP manufacturing, analytical, and stability testing.

• Aligned commercial sourcing decisions for drug substance, drug product, and packaging with stakeholders following Platform strategy ensuring program timelines and deliverables were met. Scientific Integrator, Drug Product Development (2013 – 2015) Janssen Research & Development

Managed drug development activities for strategic product cross-functional and for providing technical expertise within the CMC team.

• Led development activities for blockbuster drug that enabled progress of Ph3 Clinical trials.

• Guided launch activities for key product manufactured at external partner that led to FDA approval. Scientist, Pharmaceutical and Material Sciences (2010 – 2013) Senior Associate Scientist (2008 – 2009)

Associate Scientist (2003 – 2007)

Janssen Research & Development

Designed and executed in silico and in vitro experiments to investigate the physicochemical and biopharmaceutical properties for drug substance and drug product ensuring optimal in vivo performance. Characterized the particle properties and powder behavior to support crystallization, milling, and scale-up of drug substance and drug product. Troubleshot commercial products issues. Developed pre-formulation and liquid formulations with suitable stability and biopharmaceutical performance to define lead compounds and support preclinical studies.

• Served as pharmaceutical development SME for internal and partnered project teams.

• Managed outsourcing activities at external partners ensuring product deliverables were met.

• Implemented innovative screening process technologies to optimize scale-up concepts.

• Resolved polymorphism issue of a key product that prevented marketing disruption and provided solutions to drug substance development.

• Collaborated with different product development teams to support start of clinical studies.

• Delivered solutions to technical issues in support of Tech Transfer activities of a key product that enabled continued manufacturing and avoided marketing discontinuation.

• Established extractable and leachable database to enable validation of sourced biologics direct materials.

• Authored a “Pharmaceutical Salt Formers Selection” guidance to harmonize drug product development studies across sites.

• Developed functional reporting templates supporting global Dossier Centric process.

• Communicated responses to Health Authority inquiries about marketed products.

• Authored and reviewed technical reports and relevant sections of CMC documentation in support of regulatory submissions.

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ADDITIONAL RELATED EXPERIENCE

Chemist I, Quality Control / Quality Assurance Teva Pharmaceutical, Pomona, NY Chemist, Consumer Products GlaxoSmithKline, Clifton, NJ Scientist, Pharmaceutical Development and Validation Amoun Pharmaceutical Inc., Cairo, Egypt EDUCATION

Master of Science in Pharmaceutical Chemistry Rutgers University, New Brunswick, NJ Master of Science in Applied Chemistry New Jersey Institute of Technology, Newark, NJ Bachelor of Science in Chemistry (minors in Biology and Geology) Tanta University, Tanta, Egypt CERTIFICATIONS & PROFESSIONAL TRAININGS

• Certified Project Management Professional (PMP) Project Management Institute (PMI)

• Certified Supply Chain Professional (CSCP) Association of Supply Chain Management (APICS)

• Certified Process Excellence Yellow Belt (LEAN) Johnson & Johnson Leadership Development

• Certified Problem Solving and Decision Making Kepner Tregoe (KT)

• Flawless Project Execution (FPX) Johnson & Johnson Leadership Development

• Influence Skills Johnson & Johnson Leadership Development

• Risk Management Johnson & Johnson Leadership Development AWARDS & HONORS

• Achievement Awards: 20+ J&J awards for outstanding Leadership in support of several developmental programs.

• Leadership Development Program Graduate (BRIDGES): Janssen’s highly selective leadership program

• All Star Award: J&J Gold Encore Award for promoting “Global Connections Program” for three consecutive years.

• Gold Award: J&J Encore Award for dedicated support to “Change Agent” program. MEMBERSHIP & AFFILIATIONS

• Member, Project Management Institute (PMI)

• Member, Association of Supply Chain Management (APICS)

• Member, American Association of Pharmaceutical Scientist (AAPS)

• Member, American Chemical Society (ACS)

• Member, New Jersey Pharmaceutical Association for Science and Technology (NJPhAST)

• Member, Eastern Pharmaceutical Technology Meeting (EPTM) VOLUNTEER

• Facilitator, Janssen Credo Championship.

• Change Agent, Diversity & Inclusion.

• Coach, Piscataway Township Soccer Team.

• Team Organizer, TEDx JNJ No Boundaries Salon (2016).

• Team Organizer, TEDx JNJ Global Summit and Salon (2015).

• Facilitator, Janssen PDMS Extended Leadership Team Meeting. Page 4

ADDENDUM

PUBLICATIONS

PATENTS: Patent Holder of 6 WO Patents

(1) WO 201-***-**** A1: Salt Forms of Compound B (granted Jan 25, 2018)

(2) WO 201-***-**** A1: Crystalline Forms of Compound B (granted Jan 25, 2018)

(3) WO 201-***-**** A1: Crystalline Form of Type-2 Diabetes Compound (granted Dec 01, 2016)

(4) WO 201-***-**** A1: Antagonist of CCR2 (granted Oct 10, 2013)

(5) WO 201******* A2: Novel Crystalline Forms of Compound A (granted Nov 25, 2010)

(6) WO 200-***-**** A1: Crystalline forms of Epilepsy Product (granted Aug 30, 2007) MANUSCRIPTS:

(1) Nagy Fawzy, et. al. Lab-Scale Preparation of a Novel Cyclopenta[b]furan Chemokine Receptor Antagonist. Organic Process Research & Development Journal; 2014

PRESENTATIONS:

(1) Nagy Fawzy, et. al. In Situ Salt Screening: Pre-formulation Development for a Topoisomerase Inhibitor. Johnson & Johnson, R & D Symposium Day 2010; King of Prussia, PA

(2) Nagy Fawzy, et. al. Drug Product Technical Team in Action: Quickly Addressing a Potential Risk from a Change in API Morphology. Johnson & Johnson, Chem Pharm Science Day 2009; Raritan, NJ

(3) Nagy Fawzy, et. al. The Application of Surface Measurements on Binder Selection. Johnson & Johnson, Chem Pharm Science Day 2009; Raritan, NJ

(4) Nagy Fawzy, et. al. Understanding the Differences of Co-crystal and Salt Formation via Molecular Mechanics Calculations and Multiple Traditional Physical Chemical Techniques.

(5) Johnson & Johnson Innovative Summit; 2006; Raritan, NJ

(6) Nagy Fawzy, et. al. The design of Physicochemical Compatibility Studies for Sterile Injectable Products: Key Lessons from Recent Filings. DIA Global Meeting; 2016; Philadelphia, PA

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