Matt Marcum

• Primary Responsibilities for Role:
• Direct and supervise processes to maintain center conformity with all necessary state, federal, and organizational regulations.
• Continuously evaluate, advocate, and enhance effectiveness of quality systems in donor center through trend recognition and failure investigation in procedure execution.
• Analyze and execute processes, regulations, and SOPs to ensure quality control and overall regulatory compliance, facilitating independent decision-making and necessary modifications.
• Manage comprehensive internal and external audits, including execution and evaluation of corrective and preventive actions through effectiveness checks
• Directed personnel functions for quality assurance department, overseeing work assignments and hiring processes. Managed employee development and training programs to enhance skills and performance. Administered disciplinary actions and termination processes in compliance with policies. Maintained comprehensive personnel records to ensure accurate documentation and reporting. Oversaw work schedule management to optimize team productivity and efficiency. Delegated tasks effectively while ensuring thorough follow-up on project progress.
• increase staff expertise in job functions and connection to end product medications and patient.
• Perform, evaluate, and implement root cause analysis for deviations and customer complaints related to donor safety and product excellence.
• Projects as Quality Systems Manager:
• Collaborated with development team to create a Power BI report for company-wide deployment. Authored audit observation reports shared across the organization to enhance oversight. Supported audit response efforts and CAPA implementation at various centers as needed. Enhanced quality coverage and pre-audit preparedness for multiple operational centers. Presented powerful Power BI tools at a regional quality manager meeting in Denver, Colorado. Developed an Excel tool to automate real-time calculations for quality metrics and KPIs. Led responses to numerous audits including FDA, EMA, internal, CLIA/COLA, and PPTA audits. Conducted monthly assessments of donor centers to ensure compliance with regulatory standards.
• Led cross-functional teams to ensure compliance with quality management standards.
• Developed and implemented quality improvement initiatives to enhance product reliability.
• Led quality management initiatives to ensure compliance with regulatory standards and industry best practices.
• Developed and implemented quality assurance programs, enhancing process efficiency and product reliability.

• Led quality assurance initiatives to enhance compliance with regulatory standards.
• Developed and implemented training programs for staff on quality management best practices.
• Conducted regular audits to identify areas for process improvement and compliance gaps.
• Collaborated with cross-functional teams to establish quality metrics and benchmarks.
• Streamlined documentation processes to ensure accuracy and traceability of quality data.
• Mentored team members in problem-solving techniques to address quality-related issues effectively.
• Analyzed quality trends to proactively address potential risks in operations.
• Facilitated root cause analysis sessions to resolve recurring quality concerns across centers.
• Championed process improvement initiatives that resulted in significant cost savings while maintaining high levels of service quality.
• Conducted regular team meetings to review progress toward quality objectives and discuss opportunities for improvement.
• Maintained accurate documentation related to quality assurance activities, audit findings, and corrective action plans for easy reference during future audits or evaluations.
• Analyzed performance metrics to identify trends, gaps, and areas for improvement within the center''s operations.
• Improved overall center quality by implementing and maintaining rigorous quality management systems.

Performed Feasibility/Method Development, Method Validation, and Sample Analysis studies under cGMP
Conducted analysis and experimentation, as needed, on substances in the laboratory with minimal supervision and uses prescribed procedures (protocols, standard operating procedures, methods, etc.).
Utilized strong organizational skills, cross-discipline knowledge, communication, and multi-tasking.
Oversaw GLP studies from quote acceptance to report finalization.
Served as points of contact for clients, communication of study progress and technical concepts.
Coordinated laboratory activities to assist department management and staff to meet client-based project requirements and ensure timelines are met.
Planned and coordinated activities to ensure workflow consistency, timelines, and compliance with all applicable regulations.

• Conducted experiments to analyze chemical compounds and materials for various applications.
• Developed and optimized analytical methods using HPLC and GC techniques.
• Collaborated with cross-functional teams to ensure compliance with regulatory standards.
• Trained junior team members on laboratory protocols and best practices.
• Implemented process improvements that enhanced lab efficiency and data accuracy.
• Designed and executed validation studies for new methodologies in material testing.
• Authored technical reports summarizing findings for internal and external stakeholders.
• Managed multiple projects simultaneously, demonstrating exceptional time management skills while maintaining high levels of accuracy.
• Mentored junior scientists, providing guidance on experimental design and data analysis.
• Developed and validated analytical methods to ensure accurate results in various assays.
• Maintained absolute integrity with report findings.
• Simultaneously managed several complex projects, meeting all pertinent milestones.

• Trace Analysis and Structural Chemistry
• Conducted complex experiments to analyze materials and validate results using advanced laboratory techniques.
• Developed and optimized protocols to enhance laboratory efficiency and accuracy in testing procedures.
• Collaborated with cross-functional teams to troubleshoot experimental challenges and refine methodologies.
• Oversaw project timelines, ensuring adherence to regulatory standards and quality control measures.
• Implemented data management systems for tracking experimental outcomes and maintaining comprehensive records.
• Implemented quality control measures throughout the experimentation process to ensure the integrity of study outcomes.

• Conducted complex analytical experiments to support product development and quality assurance initiatives.
• Developed and optimized experimental protocols, improving data accuracy and reproducibility.
• Led training sessions on lab equipment usage for new hires, promoting a culture of continuous learning within the team.
• Conducted thorough literature reviews to stay current on industry advancements and inform research directions.
• Documented changes during experiments, noting unexpected issues arising during research activities.
• Performed accurate quantitative analysis of targeted data research, collection and report preparation.
• Conducted document review, organization and quality control of data acquisition to draw relevant conclusions and direct research activities.

• Conducts analysis and experimentation, as needed, on substances in the laboratory with minimal supervision and using prescribed procedures (protocols, standard operating procedures, methods, etc.).
• Utilizes strong organizational skills, cross-discipline knowledge, communication, and multi-tasking.
• Oversees GLP studies from quote acceptance to report finalization. Serve as points of contact for clients, communication study progress and technical concepts.
• Serves as a point of contact for studies as assigned and as appropriate.
• Coordinates laboratory activities to assist department management and staff to meet client-based project requirements and ensure timelines are met.
• Plans and coordinates activities to ensure workflow consistency, timelines, and compliance with all applicable regulations.
• Completes work for research and development, and documents and reports data in a timely manner according to regulatory guidelines.

• The Associate Scientist role involves conducting analysis and experimentation on substances in the laboratory with minimal supervision and using prescribed procedures (protocols, standard operating procedures, methods, etc.).
• Completes work for research and development, GLP studies, and documents and reports data in a timely manner according to regulatory guidelines.

• Generated Budgeting, Milestones, and Timelines
• Developed Business Strategies
• Created and analyzed Financial Statements including: Balance Sheets, Income Statements, and Income Taxes
• Established materials qualifications that purported appropriate identity, quality, purity, potency,, and identity
• Established and reviewing proper laboratory equipment and safety standards
• Calibration of laboratory equipment
• Established policies, standards, and procedures of the Quality Control System
• Ensured policies, standards, and procedures were followed and maintained
• Developed and implemented financial strategies to enhance organizational growth and profitability.
• Oversaw budget preparation and forecasting processes, ensuring alignment with corporate objectives.
• Streamlined financial reporting systems to improve accuracy and timeliness of data dissemination.
• Established key performance indicators to measure financial health and operational efficiency across departments.
• Directed compliance efforts with regulatory requirements, minimizing risks associated with financial operations.
• Reduced operational costs by identifying areas for improvement and implementing cost-saving measures across various departments.