Microbiology/Immunology PhD with over 10 years of experience in preclinical therapeutic models, immunoassay development, and IVD manufacturing. A technical leader with experience bringing Pharmaceutical and IVD products from R&D to pilot scale to transfer to high volume manufacturing. Manager of Technical Operations and Process Engineering who believes in the value of creating high-performing interdisciplinary teams to help drive innovative solutions to complex challenges. Problem solver with proven ability to tackle difficult problems while focusing on business continuity, continuous improvement of existing products, and refine current processes to improve future products.𝐇𝐈𝐆𝐇𝐋𝐈𝐆𝐇𝐓𝐒• Supported successful ISO 13485:2016 Manufacturing Certification audit, serving as SME for Quality Control, Process Engineering, and Transfer. Member of cross-functional teams responsible for implementing and improving Quality Management System. Qorvo, Inc.• Transfer and technical operations lead in support of successful EUA submission, transfer, and process scale-up to over 1 million units per year for Bulk Acoustic Wave based SARS-CoV-2 assay. Qorvo, Inc.• Led a team that developed a POC hydrogel particle into over 50 multiplex immunoassays to a variety of immune, cancer and serum markers. Abcam, Inc.In my current role, I manage technical operations, technology transfer (internal/external), and process engineering. • Lead qualification of new processes• Continuous improvement of existing product/processes • Production line validation• Transferring new assaysSELECTED HIGHLIGHTS• Transfer and Tech Ops lead in support of successful EUA submission of SARS-CoV-2 assay• Qualification of low-volume production line (~8000 parts weekly)• Qualification of high-volume production line and process scale-up (~8000 parts daily)• Overhaul of control system to reduce scrap costs by more than $100,000 and improve yields by >10%• Scaled reagent formulation and line qualification for reagent formulations from pilot lots to >150 L • Created initial manufacturing control systems• Supported QMS from implementation to successful ISO 13485:2016 Manufacturing Certification• Led feasibility, design, and verification activities for assays for the veterinary IVD market. Skills: Complex Data Analysis, Compliance, Continuous Improvement, Leadership, Manufacturing, Process Improvement, Product Development, Project Management, Quality Control, QMS, Risk Management, Team building, Technical Leadership, Technical Operations, Tech Transfer, Training & Development