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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Eastview Road Home: PHONE NUMBER AVAILABLEHopkinton, MA Street Address Cell: PHONE NUMBER AVAILABLEE-mail: EMAIL AVAILABLEProfessional SummaryResults-driven Supply Chain, Manufacturing and Operations professional with 20+ years combined experience in operations, production control, purchasing, planning, scheduling, supply chain and materials & inventory management in high technology, pharmaceutical and cGMP medical device manufacturing environments.A practical, articulate, and creative team player and leader with proven supervisory and managerial abilities and an established track record of developing production schedules, utilizing MRP/ ERP systems and KPI metrics to measure performance, meet goals, objectives, and tight deadlines.Highly skilled in motivating and managing both small and large technical, non-technical and cross-functional teams in cGMP, cell production, various manufacturing and LEAN groups to achieve quality, on-time customer delivery and financial goals.ERP Systems: SAP, MFG PRO, Macola Computer Skills: TEAMS, MS Office, Excel, PowerPoint, Word, Outlook, Sharepoint,TrackWise, Phenix, INFOR, Zoom, VEEVA, FieldglassSix Sigma Yellow Belt Certified -2015 Six Sigma Green Belt Certification anticipated Fall 2024EducationNichols College; Dudley, MA Worcester State University; Worcester, MAMaster of Business Administration Bachelor of ScienceCareer ExperienceProduction Manager - Packaging/Labeling 1/2013 to PresentGenzyme Corp. - A Sanofi Company; Framingham, MAManage/supervise 15 direct reports in the labeling and packaging of one million units per year of Seprafilm Adhesion Barrier, a Class III medical device.Manage production schedule to achieve weekly/monthly/quarterly targets. Device history & batch record review, create/close SAP process orders, mentor staff, assign training and conduct performance reviews.Lead daily +QDCI Board process improvement and communication meetings within department.Collect data and report on KPIs and Metrics. Revise SOPs, open, investigate,author, close deviations and CAPAs, CCRs, HSE Events in VEEVA. Perform Root Cause Analysis, FMEA, new equipment Validation.Operations Manager 8/2011 to 1/2013Thermo Fisher BioServices; Franklin, MAOversee the 24/7 operation of the 30,000 sq. ft. bio repository of biological products for numerous biopharmaceutical customers and 3rd party labs.Facilitated shipment/receipt to and from the bio repository, ensured efficacy and safe storage of product via 24/7 temperature monitoring controls for over 150 ambient, -80C, -40C, -20C and LN2 cryogenic freezer units.Managed materials, process invoices & P.O.s, scheduled maintenance, and repairs, ensured facility staff training and safety, interfaced with customers and vendors, and produced LEAN metrics tracking.Project Manager for 25+ clients and 45 projects. Met with current and potential customers, site auditors, and visitors to facilitate site evaluation and to conduct tour presentations.Position required experience in FDA, cGMP, ISO, SHE, SOX policies and regulations. Also attention to detail, with analytical, critical thinking and reasoning skills, and ability to quickly and confidently problem solve. Interfaced with auditors, audit participation and findings reviews.Production & Materials Manager 11/2009 to 7/2011Boston Medical Products; Westboro, MAEstablished, created & maintained processes to achieve weekly production schedule in compression molding area, clean room assembly, sterilization and finished goods inventory for Boston Medical Products, a global manufacturer and supplier to the ENT industry.Supervised staff of Product Builders to meet daily goals, quality objectives, customer demand and delivery dates. Monitored supply chain, raw materials, monitor sterilization and final package assembly.Utilized MRP (Macola) for forecasting & ordering raw materials and components to supply production.Ensured safety and training of staff in compliance with Boston Medicals policies, including the Quality System, utilizing cGMP practices, FDA guidelines and SOPs. Chaired weekly Management Review & Sales Order meetings. Maintained cycle counts, critical supplies and SKUs, vendor negotiations.Production Manager 11/2008 to 5/2009Creganna-TacTx Medical Devices; Marlboro, MASupervised twenty-five product Builders and technicians in an assembly line cell operation in Cregannas Endoscope needles Assembly Department. Ensured all Product Builders were trained to cGMP guidelines, utilizing company SOPs and QA documentation. LEAN/Kaizen events facilitator.Set the production schedule in the ENDO Needles Assembly department to achieve weekly goals. Worked closely with vendors to meet manufacturing requirements. Purchased all raw materials, supplies. Identified cost savings in first 3 months in the role.Generated P.O.s, prioritized incoming inspection of raw materials, and components, maintained cycle counts and inventory. Prepared and modified BOMs and routers, issued/processed work orders. Reviewed DHRs/CHRs to ensure all production jobs, lots and batches were compliant.Maintained, tracked, and reported performance metrics to executive management, i.e. - in-process yields, safety, labor efficiency, machine capacity & on-time delivery. Increased Endoscopic Needle production from 200 to 1,000/ wk. and increased product yield acceptance from 55% to 88% within 30 days of Kaizen Event.Senior Demand Analyst 5/2007 to 10/2008Cytyc-Hologic Corp; Marlboro, MASupply chain team member responsible for facilitating the transition of Mountain View, CA operations, manufacturing processes, organizational tasks, and related documentation from the West Coast facility to Cytyc-Hologics Marlboro plant.Monitored the off-shore Costa Rica production schedule for NovaSure and MammoSite product lines to meet Cytyc-Hologics Surgical Division ($125M annual) sales forecast. Was the primary contact between manufacturing, sterilization facilities, freight carriers, QC and Hologics Global Distribution Center in Methuen, Massachusetts.Analyzed raw materials, components, WIP and Finished Goods to achieve safety stock levels to meet sales forecast. Made recommendations to purchasing and production based on analysis. Participated in reviews and preparations of BOMs and routers in MFG PRO (MRP).Interfaced daily with Quality, Marketing, Manufacturing, Purchasing, and Engineering to identify, prioritize, and resolve work-in-process constraints impacting the production schedule and customer delivery.Production Manager 1992 to 2007Newport Corporation; Franklin, MA (previously Thermo Fisher Corp. & Corning, Inc., Marlboro, MA)Manage a staff of seven production planners, shipping/receiving and stockroom personnel in a thin-film vacuum deposition coating and optics manufacturing facility.Reviewed customer orders, analyzed/ordered raw materials, planned, and executed production schedules from ion deposition coating through finished goods to customer order fulfillment.R & D (PRC) Supervisor in start-up of Cornings Production Realization Center transitioning prototypes to rapid manufacturability.Supervised 12 technicians and Engineers in the PRC department to meet aggressive ramp up in manufacturing schedule of Wavelength Division Multiplexers (WDMs) for the telecom market.Group Leader supervising workflow of several optical technicians in the preparation, coating, assembly, and packaging of complex optical substrates and components.Program Manager for the M-1 Military tank replicated mirror contract. Monitored and controlled labor and material costs to meet manufacturing schedule within an allocated budget. |
