Building and qualifying a strategic supplier network for molecular diagnostic reagents for IVD medical device production and manufacturing Quoting, contract negotiation, and cost management for contract manufacturing of medical device componentsDeveloping, leading, and executing supply strategies including strategic qualification of alternative materials and sourcing of supply adhering to ISO 13485 medical device regulations Preparing requests for proposals, overseeing the process, performing price analyses and cost modeling for materials/servicesMaintaining supplier relationships and acting as a liaison for resolving supplier/material related issues on assigned materials/services for the sterilization and molecular diagnostic reagent categories of spendEvaluating supplier reagent cGMP production capabilities and conducting market analysis of demandInitiating and leading cost reduction and continuous improvement programs using alternative materials/sourcesDrafting of contracts and ensuring compliance to legal and internal/external regulations and policies

Planning and directing the movement of materials from international and domestic clinical supply sites to researchers and laboratories for custom pharmaceutical developmentTracking supplier site scheduling, clinical kit production, and packaging for delivery of custom clinical sample kits to supplier sites for clinical research to meet study deadlinesGathering and analyzing data from inventory systems, quality data, and sales outputs to create comprehensive reports in Excel for both internal and stakeholders to raise strategic awareness of supply and demandDesigning and implementing procurement plans to replenish the sample oncology biobank inventory and forecast collection of samples and materials to support pharmaceutical drug development Driving the wider cross-functional teams to continously optimize clinical supply availability and inventory investments by communicating statuses, dates, and sample deliverablesManaging, negotiating, and improving supplier relationships to increase the number of preferred suppliers, reduce costs, improve deliverable quality, and shorten delivery to promise time Complete management of the custom procurement logistics including creating the standard operating procedure for sample logistics, negotiating the pricing contract and tarriffs, and arranging the daily shipment movements of trial samples to sponsorsProviding project management solutions to supplier problems throughout project cycle to enhance the global supply chain networkCreating and monitoring the project budget, cost modeling, material handling, purchase orders, and receipt material recordsStrong proficiency in Sage ERP X3 and PC Microsoft programs (Office 365, Word, Excel, PowerPoint, etc.) Ensuring that all required protocol and regulatory standards are following including: ICH-GCP, ISO, GLP, FDA, HIPAA, IRB approvals, and SOPsCommunicating with clients as a subject matter expert to discuss supply chain needs, timelines, goals, and market demands

Directing central procurement of biological clinical research samples at two donor site tissue bank teams for pharmaceutical and medical device studies in response to research demand while adhering to FDA regulationsCreating, defining, and executing a procurement request tracking system to ensure samples collected meet the highest quality, requested protocols, and promise datesUsing strong customer service knowledge to communicate directly with both clients, vendors, and all levels of management project progress data to establish strong long-term client relationships, researching problems, identifying risks, and problem-solving solutions Negotiating pricing and contract terms with clients in response to clinical research contract needsAccounting and administration experience managing all company invoicing and accounts receivable collections Record management experience pertaining to shipment documents, invoices, and cost trackingMonitoring purchasing of two procurement sites, customer demand, orders, and budgets to achieve 20% growth each quarter

Applying appropriate and defined methodology to manage confidentially detailed records, consent forms, and project tasks for the clinical research donation processConsenting patients via an approved ICF for participation in clinical research Tracking supplier costs for projects and implementing a team strategy to increase awareness of medical research benefits Providing feedback to project team and leaders on cost concerns

Reviewing clinical trial data for the company newsletter to chronic pain patientsAddressing customer concerns and assisting in order processing

Worked with and implemented the care programs of recovering brain-injury patients and children with neurological disorders

Microbiology and Molecular Genetic laboratory experience performing and planning procedures measuring gene and protein level expressionProficiency in Real-Time PCR, RNA and protein extraction, Generation of cDNA Libraries by Reverse Transcription, as well as Plasmid Purification and DNA MicroarraysMaintaining detailed records of experimental procedures and analyzing results for PresentationPerformed DNA, RNA, and Protein extraction, Restriction Enzyme Digestion, Ligation, Plasmid Purification, RT PCR, Gel Electrophoresis, and Sequencing as well as DNA MicroarraysGained experience working with cell cultures and proficient knowledge of modern molecular biology research methodsFollowing Laboratory Protocols, Documentation, Statistical Analysis, and Data Preparation