Maradi Pho, MBS

• Oversight of end-to-end cGMP operations and assurance that the clinical productions meet the Food and Drug Administrations (FDA) regulatory requirements including, managing plans, deliverables and timelines, manufacturing, quality control and testing, proper documentation and record keeping, drug accountability, distribution, procurement • Developed, drafted and reviewed standard operating procedure (SOPs), master batch records (MBRs), certificate of analysis (CoA), validation protocols, IQ/OQ/PQ, ensuring product integrity, regulatory compliance and audit readiness • Directed cross functional teams through product development lifecycles, driving alignment, workflow clarity, and structure strengthening overall operational performance and outcomes • Led complex projects; new product development, process improvements and design solutions that drive innovation, automation and standardization to reduce variability and risk, enhance product integrity, safety and quality, optimizing efficiency and throughput • Built high performing teams across operations, manufacturing, R&D, engineering; oversee hiring, onboarding, training, and performance management while promoting professional growth and employee retention • Primary point of contact for complex operational challenges; define, measure, analyze, improve, control, document discrepancies, evaluate, troubleshoot and resolve critical issues, identify bottlenecks and coordinate cross functional response efforts

Represent the Master of Biological Sciences program to elevate graduate student learning experiences.

•Produced pharmaceutical products by setting-up, sanitizing, operating, and maintaining equipment; adhering to current good manufacturing practices (cGMP) and good documentation practices (GDP) •Utilized manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change while in compliance with all regulations •Developed and maintained training materials and curricula on process operations and the scheduling and training of new employees- with minimal direction and supervision •Actively researched, evaluated and compared pricing from suppliers ensuring optimal savings while purchasing quality products essential for daily operations of the entire site •Strategically planned all purchases to maintain an organized inventory, adapting to market changes and communicating to cross functional teams •Continuously built good rapport with all vendors and suppliers ensuring competitive advantage

•Supervised all billing staff to ensure accuracy and efficiency of payroll, finances and claims •Implemented policies and procedures for billing reconciliation and evaluated potential areas of improvement •Performed strategic planning to minimize loss and maximize gain of revenue and communicated objectives to cross-functional departments •Prepared weekly billing and financial reports for tracking budget expenses and reported findings directly to Chief Executive Officer

•Reviewed payer specific websites and their policies to correctly and accurately process authorizations for patient needs •Examined structured clinical data matching it against patient specific diagnosis and orders •Communicated efficiently and effectively when calling physician’s offices, hospitals and payers •Trained new employees on processes and educated them on company best practice

•Managed daily purchasing of equipment and supplies by checking stock ensuring adequate inventory levels •Maintained lab budget by actively researching and comparing supply companies, negotiating contracts and building good rapport •Executed an organized system of documentation and maintenance of goods ordered and received •Authorized payment in a timely manner for purchases received minimizing outstanding balances

•Acquired a variety of molecular biology techniques such as DNA extraction, PCR, genotyping, primer design, tissue culture •Performed experiments independently paying close attention to detail and careful record keeping •Collaborated with lab personnel to conduct experiments, analyze data and interpret results for research goals