Lauren Moyer Email and Phone Number

• Supervise laboratory activities for non-GMP and GMP testing of combination products and medical devices.• Author, review, and approve GMP documents such as validation protocols, validation reports, test methods, and SOPs.• Author, review, and approve quality system events such as deviations and laboratory investigations.• Implement continuous improvement initiatives to increase efficiency and quality of testing.• Conduct internal audits of GMP testing laboratory and assist with client audits.• Oversee sample management, laboratory safety, and waste management.• Manage instrument calibration and maintenance to maintain GMP compliance.• Assist product development team with testing requirements, test fixture design, and product design.

• Developed and executed test methods per ASTM and ISO standards for feasibility, validation, and routine testing of medical devices and medical device packaging systems under GMP and ISO 17025 guidelines• Designed and fabricated custom test fixtures and test equipment based on client-specific testing requirements. • Developed Instron test programming to onboard new test offerings such as catheter testing and vial testing• Lead author and editor for analytical reports, methods, and protocols; Responsible for creating document templates • Conducted root cause investigations and established corrective/preventive actions • Subject matter expert in customer facing engagements to develop testing strategies and communicate results• Improved testing efficiency and equipment utilization through LEAN initiatives• Trained new analysts on equipment and test methods• Selected to participate in Leadership Academy for Emerging Leaders (Jan-Apr 2023)• Served as certified My Green Lab Ambassador to drive green initiatives in the Package Testing Lab

• Advised engineering students on resumes, LinkedIn, and internship searches• Supported Career Services Staff with filing student reports, updating handouts, and other office tasks

• Designed device to guide surgeon to insert a left ventricular assist device in the correct position and angle in the heart• Researched current solutions and patents and potential use of ultrasound, mechanical sensors, and augmented reality• Performed dimensional analysis using Geometer’s Sketchpad to allow for 10° of rotation within set parameters• Prepared and edited project reports; Presented design process to professors, peers, and industry experts• Worked closely with the machine shop to communicate design and construct device out of aluminum

• Assisted Ph.D. student on introducing Cas9 into chickens for Marek’s Disease immunity• Ran PCR and gel electrophoresis to analyze presence of Cas9 gene• Executed Western Blot to analyze expression of Cas9 in various tissues• Analyzed experimental results to characterize Cas9-mutated chickens at genetic, tissue, and organism levels

• Investigated improvements to depth of cure for light-cured dental materials • Developed testing methods to measure and compare irradiance of multiple materials• Analyzed data to create predictable model improving light transmission of materials• Designed a prototype material to optimize light transmission and deflection• Presented findings to an international video conference

• Facilitated the design, construction, and programming of the over-sand vehicle for chemical neutralization mission where vehicle autonomously navigates to a polluted pool and tests the pH • Designed and tested the electric circuit such that the vehicle could navigate to the pool and test the pH • Co-wrote and presented report on overall design and performance of over-sand vehicle