Supports and coaches a team of Materials Planners for a multitude of clients at the Harmans Manufacturing facility. Coordinates cross functional teams that support the GMP material supply chain including Purchasing, Quality Control, Program Management and Materials Control. Escalates material concerns with vendors to schedule and expedite shipments to maintain production schedules. Synchronizes BOM data within the ERP system using input from Manufacturing Sciences and Manufacturing to ensure appropriate materials are issued for production. Assists Data Stewards to ensure proper consumption occurs within ERP. Creates costed BOMs and campaign budgets for production runs ensuring consistent invoicing and AR cash flow. Shares forecast schedules with key suppliers to ensure stable material availability and reduce warehousing costs by negotiating delivery schedules that minimize storage times. Involved in Quality functions such as change management, document reviews, and lot tracing within the ERP system.

Supported multiple client programs by managing their raw material procurement needs for manufacturing gene therapy products in clinical trials. Cultivated relationships with suppliers to establish consistent pricing and delivery schedules for consumables needed to maintain production for our manufacturing suites. Worked with Process Development and Manufacturing Science to review BOMs and developed material alternates and secondary suppliers. Utilized software to create BOM builds, create production orders and picklists, and generate purchase requisitions for internal approval. Tracked raw materials from PO generation through order fulfillment. Teamed with Quality Assurance to release materials, Materials Control to issue Materials, and Accounting for batch costing.

Worked in the downstream manufacturing of a cGMP company producing Phase I and II biological pharmaceuticals. Harvested viruses, mammalian RNA, and other animal proteins from various biological sources; purified them using different types of centrifugation, microfiltration, and ultrafiltration equipment; and prepared bulk drug product or pre-portioned drug vials per FDA requirements. Wrote technical training guides, SOPs, batch records, tubing assembly designs, and work instructions for new processes and equipment. Compiled data to produce final batch and experimental reports. Initiated and researched process deviation and corrective action reports using Trackwise and appropriate business tools/continuous improvement processes. Training coordinator for the department and designated trainer for all new hires in ISO 8 and ISO 7 aseptic gowning procedures. Transitioned legacy training platform into ComplianceWire and updated and maintained appropriate training curriculums. Worked with our process development team to scale up production activities by producing specifications for materials, equipment, and consumables. Worked with vendors to create purchase requisitions and competitive bidding requests for equipment, chemicals, and other materials. Experienced in aseptic sampling procedures.

Produced specialized media for medical and environmental testing departments at the State laboratory. Thorough knowledge and experience in microbiological and chemical principles and techniques, including media and reagent production and their quality control. Extensive use of complex computer software applications, databases, and computer systems including LIMS, data base applications, and word processing. Experienced in utilizing built-in testing and quality assurance processes to assure quality products for the internal customers. Revised and tested SOPs and new equipment while troubleshooting issues and creating corrective action plans for fixing the equipment. Ability to train employees and interns, delegate responsibilities, and evaluate employee performance for process improvements. . Proven ability to plan, multi-task, manage multiple priorities, and organize workload to adhere to a structured production schedule. Experienced in inventory auditing and making appropriate inventory corrections in Excel and in LIMS. Ability to maintain a current inventory of stock and insure acquisition of necessary supplies. High level of ability in oral and written communication. Trained in ISO 17025, CLIA, FDA, and other standard regulatory protocols.