Diana Storms

Promoted internally to the product development department for delivering the highest-quality work with outstanding attention to detail. A crucial member of a multifaceted project team provided leadership in developing point-of-care diagnostics products from the feasibility stage to validation and manufacturing integration. Key member in executing experimental plans wrote and followed standard operating procedures for in vitro diagnostics assays under the guidance of experienced senior professionals. * Attain quality product development and product design change implementations occur accurately using documentation under design control. * Experience with assay and product development and bringing IVD products to market. * Supported need during global pandemic by creating and releasing COVID-19 assay in just six months. * Generated $250,000 per annum cost savings by in-sourcing the manufacturing of paramagnetic particles

Advanced within company to formulate reagents and conduct experiments in manufacturing. Participated as member of cross-functional products development teams and planned/implemented immunoassay, hardware, software, and/or next generation systems development projects from feasibility through regulatory clearance/approval. * Insured highest quality products possible using DOE methods and performing statistical analysis and practices. * Optimized TSH assays incubation duration from 16 minutes to 11 using different protein linkers for conjugate. * Contributed to technical support department receiving erroneous results; used troubleshooting acumen to test results and root cause analysis to determine short sampling as reason for inaccuracy.

Global Leader in the development, manufacture, and marketing of Molecular Assays (nucleic acid amplification technologies, -NAATs) that quickly/accurately detect diseases. Performed HIV-1/HVC multiplex as well as dHIV-1 and dHCV Molecular Assays (nucleic acid amplification base assays). Developed experiments and analyzed data/presented findings. Facilitated training and leveraged automated diagnostic instruments such as Transcription Mediated Amplification assays, Leader HC, Leader HC+, and TIGRIS instrument. Delivered Results: * Excellent understanding of Hologic (Gen-Probe) Nucleic Acid Amplification Technology (NAAT) – Transcript Mediated Amplification (TMA), Hybridization Protection Assay (HPA), target capture * Validated the Crimson Leader HC solution and developed/improved a new prototype instrument for amplified mRNA detection. * Instituted Reagent Stability Project and established optimal stability conditions by varying temperatures and pH values across gradients.