Maria Denayer

Experience

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  Quest Diagnostics

  Aug 1998 - Mar 2000

  Product Support Technician

  - Compounded and analyzed immunoassay diagnostic kits, leading Stability Testing of raw materials with cGLP regulations- Effectively analyzed and resolved current and new radio isotopic and immunoassays, including customer’s technical issues- Supported R&D assay development, validation, production scale up, and transfer to the Nichols Advantage Machine

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  Genentech

  May 2000 - Dec 2005

  Senior Manufacturing Technician

  - Shift lead in operating large-scale production of mammalian culture- Operated and turned over fixed tanks systems, column chromatography units, and freeze-thaw units- Collaborated with validation for new product introduction - Initiated and closed discrepancies and CAPA’s via Track wise, troubleshot manufacturing incidences using PIDs, Visio and PLCs- Performed media/buffer solution preparation operations in compliance with GMP, SOP’s, and manufacturing formulas- Maintained records and clean room environment complying with regulatory FDA standards and requirements Show less

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  BioMarin

  Oct 2012 - Oct 2013

  Manufacturing Technician

  - Supported the Fermentation and Purification Operations department to achieve department goals and priorities- Prepared buffers and media, collecting and submitting in-process samples while maintaining inventory - Tracked raw material, preparing, cleaning, and sterilizing process equipment, CIP units, autoclave, and lab washers- Troubleshot equipment and process failures, assisting with equipment and process validation- Supported facilities in changeover, completing PM’s UFDF, Chromatography Skids, CIP Skids, RO units, and HPLC - Actively pursued, supported and executed process changes, contributing to and reducing process deviations- Monitored RO, WFI, Process Equipment, and utilities within manufacturing documenting events and deviations- Reviewed and modified controlled documents and complied with cGMP, FDA,OSHA and ISO Standards- Maintained inventory control by performing cycle counts and adjusting counts with EBS system- Determined and reported deviation root causes in Oracle system- Submitted and tracked work orders via CMMS, identifying, reporting, and resolving safety issues in Mira share Show less

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  XOMA

  Oct 2013 - Apr 2014

  Process Associate II, Process and Manufacturing Sciences Team

  - Monitored and maintained raw material components and materials in manufacturing area, managing transfers- Performed downstream operations for clinical manufacturing according to technology transfer report - Used purification processes such as column chromatography, UFDF, TFF, viral inactivation, filtration of bulk drug substance, and final formulation- Troubleshot and modified process and batch records as needed to ensure accurate tracking and recording- Participated and supported manufacturing investigations and deviations, executing corrective actions and PCRs- Set-up, calibrated, maintained, and performed PM's on chromatography skids, ultra-filtration units, spectrophotometers, osmometers, and filter integrity test units, submitting samples for QC analysis- Assisted technology department in executing purification processes, developing and characterizing experiments - Created, revised, reviewed, ordered, and archived batch records, SOP's and other manufacturing documents- Submitted CWO's, EWO's, and PO's as needed assisting QA with inline clearance prior to campaign changeover Show less

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  Siluria Technologies, Inc.

  May 2014 - Nov 2017

  - Transitioned company’s manufacturing MRP from Quickbooks to SAP Business One- Maintained inventory on SAP/QuickBooks MRP, accounting for remote Siluria sites and CMO's- Created build assemblies and work orders for production batches using SAP to ensure consistency and reliability- Procured raw material, supplies, and equipment, allocating production of finished goods and universal database- Set-up logistics and assisted in shipping final product to Demo and CMO's- Collaborated with forming and cross functional groups to determine and define company product demand- Planned, scheduled and aligned resources to effectively meet and achieve organization goals and priorities- Received, reviewed, tested, and released raw material inventory and production batches - Maintained and reported day-to-day ERP production reports for raw materials and production batches- Reported, investigated, and reconciled inventory discrepancies- Analyzed, interpreted, and reported data to broader Research and Development- Implemented QA and QC systems for raw materials and final batch release Show less - Saved $1M by building and commissioning 16 channel methane -to- ethylene reactor- Designed and sourced materials which led to an increase in 16 channel reactor run efficiency by 300% - Maintained and reported day-to-day ERP production and raw material reports - Maintained physical inventory for forming and chemistry lab and decremented materials as needed using Quickbooks MRP- Created build assemblies and work orders for production batches using Quickbooks MRP - Led various process improvement projects with process and equipment to reduce operational costs- Sourced, validated, and qualified characterization equipment and chemical supplies- Tracked and assisted production batch shipping via GPS trackers, allocating production in universal MRP database - Created and composed SOP and form documents for technical operating and maintenance documents- Developed process control test procedures for tapping densities, incipient wetness, and particle distribution- Responsible for building, commissioning, diagnosing, and troubleshooting 16 Channel reactors- Created and Managed SPC Charts while maintaining characterization data in JMP and Excel- Synthesized, characterized, and tested catalysts to support discovery, catalyst development groups, and manufacturing group Show less

  • Staff Process Associate/Planner, Forming Group

    Feb 2017 - Nov 2017

  • Research Associate, Catalyst Development

    May 2014 - Feb 2017
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  Clean Harbors

  Jun 2018 - Dec 2020

  Supply Planning Manager

  - Successfully diverted in bound shipments of $3 million in re-refined base oils and additives during Covid shutdown which prevented demurrage fees of $5K per month- Responsible for annual plant savings of $30K by leading process to substitute bulk car additive deliveries in lieu of drum deliveries- Owned sourcing for launch of military dedicated division consisting of 20 new products, increasing the monthly sales by $100K- Key POC for British Petroleum oils, with KPP as a 3rd party supplier and ensured receipt of supply rail cars to satisfy customer orders via outbound shipments of bulk truck in-full and on-time deliveries which comprises 35% of plant income- Developed and maintained daily/monthly/weekly production schedule/supply plan for assigned product lines and manufacturing facilities that is aligned with customer demand, sales forecast, inventory targets and available capacity using the JDA planning system. - Developed and maintained RCCP to determine when production may exceed the desired capacity to demand ratio - Balanced production and inventory levels with demand to support targets within consistent customer service levels, inventory turn targets, and capacity utilization requirements between multiple distribution centers and production facilities ** - Communicated production schedule and coordinated all functions responsible for maintaining production stability, optimal inventory levels and resource utilization per company policies, while meeting the needs of the customers- Maintained strategic relationships with existing internal and external vendors on a global level- Participated in weekly calls with global planners to report and identify raw material excess or constraints - Identify, monitor, procure, and receive raw materials for production while maintaining a lean safety stock- Supported NPI's by coordinating with suppliers, manufacturing, design, and marketing to ensure all raw materials were available for product launch Show less

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  ISLAND

  Dec 2020 - Sept 2021

  Supply Chain Manager

  - Led inventory team by developing and implementing inventory audit processes. Discrepancies improved from 53% to .001% after process changes. - Facilitated transition from DTR to 3PL Nabis resulting in the reduction of transportation costs by 10% - Launched EAZE Compassion project redirecting $8K of Cannibus product from destruction- Identified a 60% overshoot of monthly forecast and adjusted demand calculations improving forecast accuracy to 99.90%- Developed and implemented effective metrics for the Demand Planning function aligned with delivering business objectives - Proposed weekly production plan based on demand, production constraints, and raw material availability - Developed and communicated demand plan to all areas of the business, including Finance, Sales, Operations, Procurement, and Logistics - Collaborated with sales and production to resolve priorities regarding customer demand - Monitored distributor and on-site inventory to avoid OOS - Assisted Sales with weekly Customer and DC allocations - Presented KPI’s for monthly/weekly SIOP reporting at the executive level - Interfaced across multiple teams to develop forecasts for new products Show less

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  Bio-Rad Laboratories

  Jan 2022 - now

  Technical Project Manager, Global Supply Chain Business Process and Systems

  - Led $3M in savings for Q2, 2022. 30% reduction in errors achieved by gathering user stories, identifying root cause, leading process changes, and deploying training for MRP parameter optimization- Identified missed shipments valuing $9M. Goal achieved by launching and developing on-time, in-full monthly KPI report - Integral collaborator for Kinaxis MRP implementation by gathering technical business requirements, functional design requirements, and identifying Kinaxis master data parameters for end users, consisting of 13 distribution centers and 6 manufacturing sites for EMEA, APAC, & AMER- Contributed to agile ceremonies, attended daily scrums, sprint review discussions, and sprint demos for Kinaxis implementation- Drove collection and processed user data for end-to end Kinaxis validation across +20 global distribution centers, each containing approximately 90K SKUs with >20 parameters- Interim lead for 7 person deployment team - Designed, coordinated, and implemented road maps for system and business changes between cross functional groups- Drove, validated, and documented Master Data Changes in SAP, Power Bi, and Kinaxis Rapid Response Systems- Trained and prepared deployment team for Kinaxis Rapid Response system launch Show less