Chris R Fong Email & Phone Number

New York, Ny, Us

Rockville, Maryland, United States

Oversee and lead teams responsible for:-Technical Onboarding, Activation and Management: Lead the evaluation, setup and activation of treatment sites for clinical studies and the preparation for commercial CAR-T apheresis and therapy administration.-Patient Scheduling and Logistics: Manage patient scheduling at treatment sites, including logistics for leukapheresis and drug product handling.-Corporate Logistics: Establish and oversee logistics network and service providers which includes small parcel shipments, special courier services, and the handling of raw and critical starting materials.-Cell Orchestration Platform: Oversee the platform portal and strategic delivery roadmap that enables treatment sites to register patients, select leukapheresis and manufacturing slots, and monitor the patient's cell journey.-Team Development and Leadership: Establish a collaborative and high-performing team through effective leadership, mentoring, and professional development, aligning with department and company goals.

Rockville, Maryland, United States

Developed and created logistics processes and solutions for Cell Therapy Pivotal Phase Clinical startup. Utilized commercial and international biopharma experience and foresight to implement an agile and scalable Distribution, Transportation, Import/Export and Cold Chain network.-Established logistics commercialization operations and organization strategy which incorporates site selection and training providing a rapid approach to site on boarding, activation and launch execution-Improved logistics repeatability, reliability and speed by evaluating risk, introducing layered contingency measures, utilizing alternative routing and modes of transport-Partnered, educated and advised cross functionally to ensure logistics requirements and dependencies are integrated enabling quality, compliant and timely transport

Rockville, Maryland

-Developed an efficient and effective Logistics model which yielded compliant, quality, and operational processes -Implemented key transportation providers utilizing a risk-based approach of special couriers, hand carry and charter services to transport time and temperature sensitive material -Executed an Import/Export compliance strategic roadmap to improve awareness, processes, training and compliance mindset achieving privileged customs certification-Designed and executed agile and scalable Shipping Qualification method for BLA filing by establishing master plan with supporting procedures, templates, protocols and reports

New Brunswick, Nj

Direct a staff of 16 managing and governing enterprise data enabling SAP, Kinaxis, Quality and Regulatory systems and processes in addition to driving enterprise data transformation initiatives.-Transforming organization by executing an Operational Kaizen reshaping current work, integrating work of the future, simplifying processes and developing capabilities to enable greater output and value.-Redesigning E2E batch differentiation, identification and market release processes and system use to improve and strengthen market compliance controls.-Exploring advancement of supply chain data use and value beyond data quality by initiating internal and external summits with the intent of piloting leading use cases.-Improved Data Quality program data quality, accuracy and consistency KPIs by 85%. Expanded governed critical data. Instituted sustainability with a Data Asset culture and a user adherence audit program

Oversee global transportation partners, cold chain and security organization establishing global systems, standards and strategies driving core and growth business while ensuring product integrity, compliance and cost effectiveness.Transportation | Logistics | Cold Chain | GMP/GDP | FDA | EMEA | Compliance | Risk Mitigation | Continuous Improvement | Six Sigma | Cross-functional Collaboration | Project Management | Staff Development & Management | Performance KPIs

Led global transportation, cold chain, transport validation and trade compliance of 12 staff enabling compliant and cost effective logistics by monitoring regulations, establishing global solutions, standards and strategy.-Established cold chain program mitigating end to end distribution risks, implementing cold chain solutions and creating monitoring process continuously improving systems and processes-Designed a specialized global distribution network managing highly sensitive time and temperature sensitive -70°C product through storage, pick/pack, tracking and receipt.-Collaborated with regional and site stakeholders creating global transport sourcing strategy, rationalizing requirements and consolidated spend. Negotiated global contracts and volume rebate reducing cost 12%-Managed transportation suppliers implementing balanced scorecard with key metrics and targets improving supplier accountability, pricing and operational performanceTransportation | Transport Validation | Logistics | Cold Chain | GMP/GDP | FDA | EMEA | Compliance | Regulatory Filing | Risk Mitigation | Continuous Improvement | Six Sigma | Cross-functional Collaboration | Project Management | Staff Development & Management | Performance KPIs

Established a global product packaging serialization program acquiring cross-functional management sponsorship, modifying packaging lines, managing 3rd party suppliers, transforming SAP system and supply chain processes complying with evolving global serialization regulations. Implemented pilot line on time and on budget.SAP | Cross-functional Collaboration | Supplier Management | Process Optimization | Strategic | FDA | EMEA | Compliance | Project and Budget Management | Contractor Management

Managed 17 staff supporting $2B in commercial revenue and clinical GMP/GDP distribution operations. Responsible for ensuring safe, compliant, cost, inventory management and performance objectives were achieved.-Optimized GMP/GDP Standard Operating Procedures (SOPs) and operations reducing distribution non-conformances 41%. Managed partner and regulator inspections without major observations-Managed staff setting development plans, goals and performance targets continuously measuring, challenging and increasing staff effectiveness-Utilized and instilled Six Sigma techniques with team reducing labor, material and freight cost 7%Warehouse | Inventory Management | Distribution | Shipping | Safety | GMP/GDP | FDA | EMEA Compliant Procedures/Standards | Risk Mitigation | LEAN | Six Sigma | Staff Development & Management | Performance KPIs

Established and managed 10 staff organization overseeing ERP Master Data Management and Governance enabling SAP systems and processes. Led cross-functional team setting, sustaining and improving data standards.-Designed and implemented new organization and governance model in collaboration with stakeholders and senior management-Motivated team ensuring standards were adhered, accuracy targets were achieved and process and systems were continually improved-Established Global Data KPI metrics sustaining and improving quality and timeliness reducing errors 80%SAP | ERP | ERP Master Data | ERP Implementation | Organization & Governance Design | Cross-functional Collaboration | Staff Development & Management | Performance KPIs

Oversaw master data management of supply chain data supporting MRP and ERP. Evaluated current state supply chain data management systems and processes establishing the global ERP implementation blueprint.-Developed SOPs, training and forums that improved system, process and people integration-Managed team to ensure master data accuracy as well as led initiatives identifying and rationalizing master data to enable constrained short and long-term planning

Managed High Density Polyethylene bottle raw materials 3rd party supplier relations and performance. Procured supply for new business development opportunities and negotiated contracts enabling sourcing strategy.-Collaborated with marketing, sales and product development designing and executing strategic sourcing initiatives through detailed market and supplier evaluations weighing total cost, service, quality, risk mitigation and supplier strategic strengths-Implemented procurement strategy reversing a sole source supplier from breaching terms. Nurtured supplier relationships ensuring supply during volatile oil and natural gas feedstock force majeure-Managed suppliers achieving 98% customer service-level metrics conducting cross-functional/company S&OP: Sales, production, inventory, capacity and expense evaluationsProcurement | Strategic Sourcing | Raw Material Management | Supplier Relation & Performance Management | Cross-functional Collaboration | Contract & Price Negotiation | Design and Material Innovation | Risk Mitigation | LEAN | Staff Development & Management | Performance KPIs

Designed long range planning integrating new process and systems capabilities. Led reporting team in design and release of logistics analytics managing project timelines delivering on time.-Conducted comprehensive user group workshops to capture business requirements, mitigate change implications and incorporate user feedback into process/system reporting-Configured and assessed daily versus weekly planning cycles, safety stock/capacity and load testing-Managed developer team in collaboratively creating report solutions meeting timelines

Managed supply chain product supply, transitions and new product launches. Provided holistic supply chain cost and inventory management optimization initiative leadership.-Managed product inventory weeks of supply, turns and service through S&OP forecasting, production scheduling and shipment process. Achieved 99.5% inventory level and customer service metric targets-Directed new product introductions in collaboration with Manufacturing, Warehouse, Transportation and R&D supporting Marketing and Sales strategy. Ensured Plan, Source, Make and Deliver execution-Conducted cross-functional DMAIC cost savings workshops. Led feasibility assessments and supply chain implementation teams realizing $2.7 million in savingsForecast Management | Supply Planning | Inventory Management | S&OP | Product Introductions | Cross-functional Collaboration | Risk Mitigation | Project & Contractor Management | LEAN | Staff Development & Management | Performance KPIs