SummaryResponsible for overseeing all aspects of laboratory operations, scientific studies, ensuring efficient and compliant testing processes, and driving continuous improvement initiatives. Reported to the CEO, required a strong background in laboratory management, regulatory compliance, and a deep understanding of medical device and pharmaceu6cal testing requirements.Primary Responsibilities• Designee of CEO, when needed.• Provided strategic leadership and direction for the laboratory operations, ensured alignment with organization goals and objectives.• Oversaw the day-to-day operations of the testing laboratory, including resource allocation workflow management and projects prioritization. • Developed and implement laboratory policies, procedures, and quality systems to ensure compliance with relevant regulatory standards, including ISO 17025 and FDA regulations. • Fostered a culture of operational excellence, quality, and continuous improvement throughout the laboratory.• Established key performance indicators (KPls) and metrics to monitor laboratory performance, efficiency and productivity.• Lead and manage a team of laboratory personnel, providing mentorship, guidance and professional development opportunities. • Ensured the laboratory maintained state-of-the art equipment, instrumentation and testing methodological advancements in the field. • Established and maintained strong relationships with clients, regulatory authorities, and industry stakeholders to understand their needs, address concerns, and drive customer satisfaction.• Developed and managed the laboratory budget, including cost control measures and resource optimization.• Collaborated with the business development team to support proposal development, client engagement, and contract negotiations.• Stay current with industry best practices, standards, and regulations related to medical device testing, laboratory operations, and quality management systems.

• Created thorough validation and engineering reports with R Markdown, R studio, and Mini-tab software• Extracted data from Oracle Database using SQL queries• Utilized, collected, and analyzed data to recommend process changes and improvements• Supervised activities and projects of 3 quality engineers within the quality engineering department• Managed all quality aspects of facility and environmental systems• Determined current state process efficiencies (Cpk) and suggested process improvements for increased Cpk • Determined process risk through execution of process failure modes and analysis (pFMEA) exercises • Organized multiple validation projects through shifting priority status• Authored validation protocols with highly technical writing skills and executed protocols on manufacturing processes, equipment, and testing methods• Analyzed and determined statistical significance of test data utilizing Mini-tab and R software • Consulted as a subject matter expert with process development teams to assist in improving existing processes • Performed supplier audits to ascertain reliability of current supply chain and service contracts• Through months of data collection and analysis, discovered root cause of a problem regarding the operation of the industrial, company wide air compressor and implemented a corrective action plan to significantly reduce plant downtime

• Determined current state process efficiencies (Cpk) and suggested process improvements for increased Cpk • Improved multiple measurement systems by performing method systems analysis (MSA) with subsequent method validations• Determined process risk through execution of process failure modes and analysis (pFMEA) exercises • Organized multiple validation projects through shifting priority status• Authored validation protocols with highly technical writing skills and executed protocols on manufacturing processes, equipment, and testing methods• Analyzed and determined statistical significance of test data utilizing Mini-tab and R software • Created thorough validation and engineering reports with R Markdown, R studio, and Mini-tab software• Utilized, collected, and analyzed data to recommend process changes and improvements• Consulted as a subject matter expert with process development teams to assist in improving existing processes • Performed supplier audits to ascertain reliability of current supply chain and service contracts• Through months of data collection and analysis, discovered root cause of a problem regarding the operation of the industrial, company wide air compressor and implemented a corrective action plan to significantly reduce plant downtime

• Established a quality control plan (QCP) to address facility wide microbiological critical control points based on Hazard Analysis and Critical Control Point (HACCP) evaluations• Directed research studies designed to statistically verify internal testing procedures• Collaborated with numerous cross-departmental teams to generate risk based FMEAs to determine critical to quality control points• Served as the Microbiology Manager across three different facilities • Generated non-conformance reports and led investigation teams to uncover root causes, implement corrective actions, and perform efficacy checks• Hosted regulatory auditors (FDA, MHRA, ISO) and customer appointed auditors and established an environmental monitoring program with ISO certified clean rooms• Authored cleaning validation master plan and implemented applicable procedures• Mapped multiple process flows to help visualize procedural decision points and identify potential gaps• Organized and managed development of a fully operational QC Microbiological Testing Laboratory from the ground up, including writing all procedures, designing space, ordering equipment, hiring staff, and integrating pre-existing company operations• Saved Ultradent $100k a year through lab creation by offering in-house testing and providing microbiological expertise that was previously lacking• Performed audits on external vendor• Managed Corrective Actions / Preventive Actions (CAPAs) and deviation findings related to microbiological issues for the entire company• Performed risk analyses to determine probable pathogenic effects and/or spoilage potential for materials contaminated with various microorganisms• Worked in conjunction with R&D, formulations, facilities, QA and production departments to ensure required microbiological practices were in place and followed• Worked on product development teams for 510k submissions as an Advisor/ Consultant for microbiological regulatory guidelines and consideration

• Validated a surface swab sampling testing procedure• Initiated HACCP cleaning program • Initiated ATP testing on high risk production machinery to avoid cross contamination • Monitored facility DI water system • Trained a Lab Technician in methods and skills required for laboratory work • Managed an environmental monitoring program that was utilized companywide to gain an understanding of the environmental controls within the manufacturing facility • Established a database that contained microbiology test results and monitored stability testing and issued reports• Performed microbiological testing on raw materials, in process products, and finished products• Managed laboratory operations and implemented new data sheet templates to resolve inefficiencies, save time and reduce errors

• Operated multiple MegaBACE 1000 DNA sequencers simultaneously • Assessed the validity of the DNA results for further review• Instructed a new Laboratory Technician on operational methods for the MegaBACE 1000