SEYEDEH FASHANDI

(650) 464-0992 sfashandi123@gmail.com

SENIOR SUPPLY CHAIN MANAGER

INVENTORY & MATERIALS MANAGEMENT | PURCHASING | LOGISTICS & DISTRIBUTION
OFFERING EXPERTISE IN START-UP OPERATIONS IN THE BIOMEDICAL INDUSTRY
Offering extensive expertise in end-to-end supply chain management, procurement, logistics and transportation, program management, and product development. Recognized as an effective problem solver and known for commitment to continuous improvementconsistently delivering process and product improvements and cost savings in the highly regulated biomedical industry. Knowledgeable partner and supplier manager with advanced proposal, contract, and service-level management skills. Proven leadership qualitiesable to perform effectively with all levels and functions. Core competencies include: End-to-End Supply Chains Safety & Regulatory Adherence Strategic Sourcing Demand Forecasting Pre-Market Approval (PMA) Materials Management Import/Export Administration Start-up Operations Contract Negotiations FDA Compliance Product Development Global Transportation Logistics Inventory Management Purchasing ISO Certification

Proficient in Oracle, QAD, Agile, TrackWise, and Microsoft Office applications. Trained in 5S Lean and Kaizen processes.

PROFESSIONAL EXPERIENCE
HOLOGIC INC. (FORMERLY CYTYC CORP., AND ADEZA BIOMEDICAL), Sunnyvale, CA 19882013 OVERVIEW: Successful product development and supply chain management career with Hologica leading developer, manufacturer, and supplier of premium diagnostic products and services. Hired as employee number 4 to assist in the product development of a fFN (Fetal Fibronectin) Test. Promoted through a series of supply chain leadership rolesdirecting a team of up to 5 employees in a wide range of functions including forecasting, inventory management, purchasing, long-term capacity planning, and identification and implementation of process and product improvements. Managed change through accelerated growthand 2 company acquisitions in 2007. SENIOR MANAGER/DIRECTOR, SUPPLY CHAIN (19902013)

Led the start-up operations for sourcing, packaging, validation, inventory, supply, and distribution of the companys introductory productthe fFN Testto U.S. and international customers, contributing to the products development, FDA approval, and company growth to $60M in revenues.
Led the change management of the end-to-end supply chain during rapid company growth, overseeing $1M in inventory, while maintaining 99% accuracy and ensuring compliance with all regulatory and customer requirements. Expedited the FDA pre-market approval (PMA) of the fFN product by collaborating cross-functionally with regulatory, QA, and manufacturing to ensure proper packaging, distribution, and delivery of clinical trial samples. Led the sourcing, validation, and execution of labeling and packaging materials for perishable fFN product, ensuring compliance with regulatory, customer, and FedEx shipping requirements. Identified suppliers and negotiated non-standard lead times and deduct-and-hold programs for new and current product supplies, delivering materials on time and within budget that met and/or exceeded business goals. Managed supplier compliance and negotiated extensions on the shelf life of raw materials, saving ~$100k in scrapped materialsacting as a key member of the companys material review board. Directed a team of R&D, manufacturing, and quality control in the closure of corrective and preventive actions (CAPA), troubleshooting issues, identifying new suppliers for OEM parts, communicating with current suppliers, and managing samples and shipping studies to reverse any unfavorable effects on the quality of the product. Reduced facility commodities costs by ~$200k annually by renegotiating global contracts and securing standardized pricing across 9 company locations. Realized savings of $100k+ through the execution of Kaizen events, in-sourcing the specimen collection kit, and implementing improvements to the quality control inspection process. Executed a change in finished goods packaging25-pack to 5-packestablishing a new part number, leading supplier requirements, updating bill of materials, writing documentation, and managing shipping validation with R&D.

SEYEDEH FASHANDI
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SENIOR SCIENTIST (19881990)

Led the first-of-its-kind development of a stable liquid conjugate that maintained a one-year shelf life, optimizing the companys introductory productthe fFN Testwhile meeting ISO and FDA regulations.
Developed and maintained manufacturing documents and records for product lifecycle (release through production), exercising good manufacturing practices (GMP), and providing a basis for planning and inspection. Trained production personnel, ensuring consistency and quality of manufacturing processes and procedures.

PREVIOUS CAREER EXPERIENCE

SENIOR SCIENTISTGENELABS, Redwood City, CA (19871988) RESEARCH SCIENTISTMONOCLONAL ANTIBODIES, Mountain View, CA (19841987)

EDUCATION
OHIO STATE UNIVERSITY MASTER OF SCIENCE (M.S.) & BACHELOR OF SCIENCE (B.S.), BIOCHEMISTRY